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 | ISTAMARC TORIC (ETAFILCONA)) |
Generic Name | Lenses, soft contact, daily wear |
Regulation Number | 886.5925 |
Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 7500 CENTURION PKWY. JACKSONVILLE, FL 32256 |
PMA Number | N18033 |
Supplement Number | S020 |
Date Received | 07/20/1989 |
Decision Date | 12/28/1989 |
Product Code |
LPL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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