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 | PERMLENS |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | COOPERVISION, INC. 6150 STONERIDGE MALL ROAD SUITE 500 PLEASANTON, CA 94588 |
PMA Number | P780010 |
Supplement Number | S020 |
Date Received | 10/28/1998 |
Decision Date | 12/04/1998 |
Withdrawal Date
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06/11/2014 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a ten (10) year expiration date for the Permalens (perfilcon A) Hydrophilic contact lenses. The device, as modified, will be marketed under the trade name as referenced above with no change in the current indications. |
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