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 | BIOFINITY (CONFILCON A) SOFT CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
PMA Number | P080011 |
Supplement Number | S018 |
Date Received | 09/17/2012 |
Decision Date | 11/01/2012 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOPERVISION CARIBBEAN CORPORATION IN JUANA DIAZ, PUERTO RICO. |
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