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 | SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | Unilens Corp., USA 21 N Park Place Boulevard Clearwater, FL 33759 |
PMA Number | P890040 |
Supplement Number | S005 |
Date Received | 11/04/1998 |
Decision Date | 03/23/2000 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
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 Unilens Corporation, Largo, Florida. |
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