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 | CSI (CROFILCON A) EXTENDED WEAR SOFT |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY DULUTH, GA 30097 |
PMA Number | N17987 |
Supplement Number | S027 |
Date Received | 09/01/1999 |
Decision Date | 11/18/1999 |
Withdrawal Date
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06/05/2013 |
Product Code |
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 of the CTL process for the CSI(TM) Lens from San Diego, CA to Wesley Jessen, Inc., Route 173, Kilometer 1.1, El Jibaro Industrial Park, P.O. Box 1980, Cidra, Puerto Rico 00739. |
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