| Attribute | Value |
|---|---|
| Trade Name | VISTAKON (ETAFILCON A) BRAND CONTACT LENSES |
| Generic Name | CONTACT LENSES |
| Applicant | VISTAKON |
| PMA Number | N18033 |
| Supplement Number | S065 |
| Date Received | Apr 12, 2012 |
| Decision Date | May 09, 2012 |
| Product Code | LPM |
| Advisory Committee | OP |
| Supplement Type | 30-DAY NOTICE |
| Supplement Reason | PROCESS CHANGE - OTHER |
| Expedited Review Granted? | N |
| Order Approval Statement | CHANGE TO A NEW SUPPLIER OF THE CURE LAMPS USED DURING MANUFACTURING. |
| Trade Name/Applicant | Suppl. Reason/Type | Suppl. No. | Decision Date |
|---|---|---|---|
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | 30-DAY NOTICE | S064 | Mar 26, 2012 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | PROCESS CHANGE: MANUFACTURING 135 REVIEW TRACK FOR 30-DAY NOTICE | S061 | Feb 01, 2012 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S063 | Dec 15, 2011 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S062 | Dec 02, 2011 |
| VISAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S060 | Sep 14, 2011 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S059 | Jun 22, 2011 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S058 | Jun 16, 2011 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S056 | Jun 10, 2011 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | PROCESS CHANGE: PACKAGING 30-DAY NOTICE | S057 | Jun 08, 2011 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S055 | May 20, 2011 |
| VISTAKON (ETAFILCON A) CONTACT LENSES/CLEAR & VISIBILITY TINTED WITH UV BLOCKER VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S054 | Apr 07, 2011 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | PROCESS CHANGE: MANUFACTURING 135 REVIEW TRACK FOR 30-DAY NOTICE | S048 | Mar 10, 2011 |
| VISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S051 | Feb 14, 2011 |
| VISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S052 | Feb 14, 2011 |
| VISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S053 | Feb 14, 2011 |
| VISTAKON (ETAFILCON A) CONTACT LENSES/CLEAR/VISIBILITY TINTED WITH UV BLOCKER VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S049 | Nov 23, 2010 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S050 | Nov 10, 2010 |
| VISTAKON (ETAFILCON A) CONTACT LENS VISTAKON | PROCESS CHANGE: PACKAGING 135 REVIEW TRACK FOR 30-DAY NOTICE | S045 | Aug 26, 2010 |
| VISTAKON (ETAFILCON A) CONTACT LENS VISTAKON | PROCESS CHANGE: MANUFACTURING 135 REVIEW TRACK FOR 30-DAY NOTICE | S044 | Aug 09, 2010 |
| VISTAKON (ETAFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S047 | Jul 22, 2010 |
| VISTAKON (ETAFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER VISTAKON | PROCESS CHANGE: PACKAGING 30-DAY NOTICE | S046 | Apr 30, 2010 |
| VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES/CLEAR & TINTED (VISIBILITY AND COSMETICALLY) WITH UV BLOCKER VISTAKON | PROCESS CHANGE: MANUFACTURING REAL-TIME PROCESS | S042 | Feb 19, 2010 |
| VISTAKON (ETAFILCON A) CONTACT LENS VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S043 | Oct 22, 2009 |
| HEMA FOR VISTAKON (ETAFILCON A) SOFT HYDROPHILIC CONTACT LENSES VISTAKON | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S041 | May 20, 2009 |
| VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) W/UV BLOCKER VISTAKON | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SPECIFICATIONS REAL-TIME PROCESS | S040 | Oct 31, 2006 |
| ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER VISTAKON | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL REAL-TIME PROCESS | S039 | Feb 04, 2004 |
| ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER VISTAKON | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT REAL-TIME PROCESS | S038 | Jan 08, 2003 |
| ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER VISTAKON | SPECIAL(IMMEDIATE TRACK) | S037 | Mar 18, 2002 |
| ETAFILCON HYDROPHILIC CONTACT LENSES VISTAKON | PROCESS CHANGE - OTHER REAL-TIME PROCESS | S036 | Jul 30, 2001 |
| ACUVUE BRAND (ETAFILCON A) DAILY EXTENDED WEAR CONTACT LENS VISTAKON | LOCATION CHANGE: MANUFACTURER NORMAL 180 DAY TRACK | S034 | May 18, 2001 |
| ACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER VISTAKON | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COLOR ADDITIVE NORMAL 180 DAY TRACK | S035 | Apr 12, 2001 |
| ACUVUE (ETAFILCON A) CONTACT LENS VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. | LABELING CHANGE - INDICATIONS REAL-TIME PROCESS | S033 | May 05, 1999 |
| MOLDED ETAFILCON A SOFT CONTACT LENSES VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER REAL-TIME PROCESS | S032 | Mar 16, 1999 |
| ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER) VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. | LABELING CHANGE - OTHER REAL-TIME PROCESS | S031 | Jul 11, 1997 |
| ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER) VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER REAL-TIME PROCESS | S030 | May 14, 1997 |
| ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER) VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. | PROCESS CHANGE: MANUFACTURING NORMAL 180 DAY TRACK | S029 | Oct 07, 1996 |
| VISTAKON (ETAFILICON A) ACUVUE(R),SUREVUE(R) LENS VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. | PROCESS CHANGE: STERILIZATION NORMAL 180 DAY TRACK | S028 | Mar 05, 1996 |
| VISTAKON (ETAFILICON A) ACUVUE(R),SUREVUE(R) LENS VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. | LOCATION CHANGE: MANUFACTURER NORMAL 180 DAY TRACK | S027 | Feb 13, 1995 |
| VISTAKON (ETAFILICON A) HYDROPHILIC CONTACT LENS VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER NORMAL 180 DAY TRACK | S026 | Nov 04, 1993 |
| ACUVUE(R) (ETAFILICON A) HYDROPHILIC CONTACT LENS VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. | LABELING CHANGE - INDICATIONS NORMAL 180 DAY TRACK | S024 | Oct 27, 1993 |
| VISTAKON (ETAFILICON A) HYDROPHILIC CONTACT LENS VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. | OTHER NORMAL 180 DAY TRACK | S025 | Jan 24, 1991 |
| ISTAMARC TORIC (ETAFILCONA)) FRONTIER CONTACT LENSES, INC. | LABELING CHANGE - OTHER NORMAL 180 DAY TRACK | S022 | Dec 29, 1989 |
| ISTAMARC TORIC (ETAFILCONA)) FRONTIER CONTACT LENSES, INC. | LABELING CHANGE - OTHER NORMAL 180 DAY TRACK | S020 | Dec 28, 1989 |
| ISTAMARC TORIC (ETAFILCONA)) FRONTIER CONTACT LENSES, INC. | LABELING CHANGE - OTHER NORMAL 180 DAY TRACK | S021 | Oct 23, 1989 |
| ISTAMARC TORIC (ETAFILCONA)) FRONTIER CONTACT LENSES, INC. | LOCATION CHANGE: STERILIZER NORMAL 180 DAY TRACK | S019 | Sep 14, 1988 |
| VISTAMARC TORIC (ETAFILCON A) FRONTIER CONTACT LENSES, INC. | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER NORMAL 180 DAY TRACK | S015 | Feb 26, 1988 |
| ISTAMARC TORIC (ETAFILCONA)) FRONTIER CONTACT LENSES, INC. | LABELING CHANGE - OTHER SPECIAL(IMMEDIATE TRACK) | S018 | Nov 25, 1987 |
| ISTAMARC TORIC (ETAFILCONA)) FRONTIER CONTACT LENSES, INC. | LABELING CHANGE - OTHER SPECIAL(IMMEDIATE TRACK) | S017 | Oct 05, 1987 |
| VISTAMARC TORIC (ETAFILCON A) FRONTIER CONTACT LENSES, INC. | LABELING CHANGE - OTHER NORMAL 180 DAY TRACK | S016 | Jul 14, 1987 |
| HYDRO MARC LENSES (HYDROPHILIC) FRONTIER CONTACT LENSES, INC. | S013 | Dec 15, 1986 | |
| HYDRO MARC LENSES (HYDROPHILIC) FRONTIER CONTACT LENSES, INC. | S014 | Oct 15, 1986 | |
| HYDRO MARC LENSES (HYDROPHILIC) FRONTIER CONTACT LENSES, INC. | S011 | Oct 04, 1985 | |
| HYDRO MARC LENSES (HYDROPHILIC) FRONTIER CONTACT LENSES, INC. | S010 | Jun 25, 1985 | |
| HYDRO MARC LENSES (HYDROPHILIC) FRONTIER CONTACT LENSES, INC. | S006 | Aug 10, 1984 | |
| HYDRO MARC LENSES (HYDROPHILIC) FRONTIER CONTACT LENSES, INC. | S009 | Mar 29, 1984 | |
| HYDRO MARC LENSES (HYDROPHILIC) FRONTIER CONTACT LENSES, INC. | S008 | Mar 19, 1984 | |
| HYDRO MARC LENSES (HYDROPHILIC) FRONTIER CONTACT LENSES, INC. | S007 | Nov 07, 1983 | |
| VISTAMARC(TM) CONTACT LENS FRONTIER CONTACT LENSES, INC. | S004 | Nov 02, 1982 | |
| HYDRO MARC LENSES (HYDROPHILIC) FRONTIER CONTACT LENSES, INC. | S005 | Sep 09, 1982 | |
| HYDRO-MARC (ETALFILCON A) CONTACT LENES FRONTIER CONTACT LENSES, INC. | S003 | Jul 10, 1981 | |
| ACUVUE CONTACT LENS VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. | Mar 18, 1980 | ||
| HYDRO MARC LENSES (HYDROPHILIC) FRONTIER CONTACT LENSES, INC. | S001 | Oct 01, 1979 |
Please verify with original source as appropriate.