Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | VISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 7500 CENTURION PKWY. JACKSONVILLE, FL 32256 |
PMA Number | N18033 |
Supplement Number | S053 |
Date Received | 01/18/2011 |
Decision Date | 02/14/2011 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF AN ALTERNATE TEST METHOD FOR DETERMINING THE PURITY IN THE RAW MATERIAL, METHACRYLIC ACID, USED IN THE VISTAKON® (ETAFILCON A) SOFT CONTACT LENSES. |
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