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 | ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER) |
Generic Name | Lenses, soft contact, extended wear |
Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 7500 CENTURION PKWY. JACKSONVILLE, FL 32256 |
PMA Number | N18033 |
Supplement Number | S029 |
Date Received | 07/18/1996 |
Decision Date | 10/07/1996 |
Product Codes |
LPL LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A UV BLOCKER, NORBLOC(R) 7966, TO THE APPROVED MOLDED ETAFILCON A EXTENDED WEAR CONTACT LENS (CLEAR AND WITH VISIBILITY TINT), AND A MULTI-FOCAL DESIGN WHICH WAS REVIOUSLY CLEARED FOR THE DAILY WEAR ETAFILCON A LENS UNDER K953804 |
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