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 | HYDRASOFT KERATOCONUS METHAFILCON B |
Generic Name | Lenses, soft contact, daily wear |
Regulation Number | 886.5925 |
Applicant | COOPERVISION, INC. 370 WOODCLIFF DRIVE SUITE 200 FAIRPORT, NY 14450-0000 |
PMA Number | P850079 |
Supplement Number | S026 |
Date Received | 03/31/1995 |
Decision Date | 05/15/1995 |
Product Code |
LPL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Supplement |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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