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 | PERMALENS (PERFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES |
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 | S022 |
Date Received | 04/18/2001 |
Decision Date | 11/16/2001 |
Withdrawal Date
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06/11/2014 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN INITIATOR FOR THE REFERENCED DEVICES MANUFACTURED AT AN ALTERNATE MANUFACTURING SITE LOCATED IN COOPERVISION, HUNTINGTON BEACH, CALIFORNIA. |
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