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 | COOPERVISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR 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 | S008 |
Date Received | 01/24/2012 |
Decision Date | 02/23/2012 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT00597467
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Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE IN THE STORAGE CONDITIONS AWAITING AUTOMATED WET LINE INSPECTION. |
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