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 | GENTLETOUCH (NETRAFILCON A)EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS |
Generic Name | Lenses, soft contact, extended wear |
Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY DULUTH, GA 30097 |
PMA Number | P890012 |
Supplement Number | S005 |
Date Received | 02/28/2000 |
Decision Date | 05/02/2000 |
Withdrawal Date
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05/12/2009 |
Product Codes |
LPL LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site transfer to Wesley Jessen Inc., Cidra, Puerto Rico. |
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