| 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 | SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS |
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| Generic Name | Lenses, soft contact, extended wear |
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| Applicant | CooperVision, Inc.
6150 Stoneridge Mall Rd.
Suite 370
Pleasanton, CA 94588 |
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| PMA Number | P850077 |
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| Supplement Number | S023 |
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| Date Received | 04/16/1997 |
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| Decision Date | 05/19/1997 |
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| Withdrawal Date | 05/01/2014 |
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| Product Codes |
LPL LPM |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR AN ALTERNATE MOLDED LENS MANUFACTURING PROCESS FOR A MULTIFOCAL LENS DESIGN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNSOFT MULTIPLES(TM) AND IS INDICATED FOR DIALY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE PRESBYOPIC, WITH OR WITHOUT ASSOCIATED AMETROPIA. THE LENS MAY BE WORN BY PERSONS WHO REQUIRE UP TO +3.00 DIOPTERS (D) OF ADD AND WHO EXHIBIT REFRACTIVE ASTIGMATISM OF NO MORE THAN 1.50 D THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS RANGES IN SPHERICAL POWER FROM -20.00D TO +10.00 D. |
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