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Device | BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) 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 | S011 |
Date Received | 03/30/2012 |
Decision Date | 05/11/2012 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REVALIDATION OF BIOFINITY MANUFACTURING LINE #4 WITH THE FOLLOWING MANUFACTURING CHANGES: 1) AN INCREASE IN TEMPERATURE OF THE BARREL HEATER ON THE INJECTION MOLDING MACHINE; AND 2) A CONSOLIDATION CHANGE IN THE DESIGN OF THE FILL AND CLOSE MODULE. |