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 | VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B) |
Generic Name | Lens, contact (rigid gas permeable), extended wear |
Regulation Number | 886.5916 |
Applicant | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
PMA Number | P870024 |
Supplement Number | S042 |
Date Received | 07/12/1999 |
Decision Date | 01/31/2000 |
Product Code |
MWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval is for wet shipping and up to 30 day storage of the extended wear rigid gas permeable lenses in Alcon Wetting, Soakig, Conditioning and Disinfecting Solution ID 84392. |
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