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 | S030 |
Date Received | 05/02/1997 |
Decision Date | 05/14/1997 |
Product Codes |
LPL LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MAKE A MINOR CHANGE IN THE INITIATOR RATIO (INCREASED AMOUNT) FOR THE ACUVUE(R) (ETAFILCON A) CONTACT LENS, WHICH WAS APPROVED AS N18-033/S29 ON OCTOBER 7, 1996. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE CURRENT TRADE NAME WITH NO CHANGE TO THE INDICATIONS FOR USE OR THE ESTABLISHED SHELF-LIFE. |
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