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 | SOFT-55 EW APHAKIC (VIFILCON A) SOFT(HYDROPHILIC) SPHERICAL CONTACT LENS FOR EXTENDED WEAR |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | UNILENS CORPORATION USA 10431 72nd Street North Largo, FL 33777 |
PMA Number | P960039 |
Supplement Number | S002 |
Date Received | 01/29/2001 |
Decision Date | 01/03/2002 |
Withdrawal Date
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05/12/2014 |
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 THE MANUFACTURING FACILITY LOCATED AT UNILENS CORPORATION, USA, LARGO, FLORIDA. |
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