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 | NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P820021 |
Supplement Number | S025 |
Date Received | 01/17/1995 |
Decision Date | 12/13/1995 |
Withdrawal Date
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08/28/2019 |
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 LENS BLANKS FOR NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES MANUFACTURED AT CIBA VISION CORORATION, 2910 AMWILER COURT, ATLANTA, BA TO BE FINAL CURED, WET PROCESSED, TINTED, PACKGED, AND STERILIZAED AT THE ALTERNATE MANUFACTURING SITE, CIBA VISION BATAM, BATAM INDUSTRIAL PARK, LOT #204, MUKA KUNING 29433, BATAM ISLAND, INDONESIA |
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