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Device | COOPERVISION (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 | S009 |
Date Received | 01/26/2012 |
Decision Date | 02/24/2012 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL DENSITY CHECK OF THE LENS EXTRACTION/HYDRATION TANKS. |