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 | TETRAFILCON A |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
PMA Number | N17679 |
Supplement Number | S035 |
Date Received | 03/24/2011 |
Decision Date | 04/29/2011 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES IN CRITERIA FOR ACCEPTANCE FOR WATER CONTENT FROM 5% TO 2%; AND REVISION TO MAXIMUM SPECIFICATIONS OF LENS MATERIAL COMPONENTS AND THE SPECIFICATION FOR WATER CONTENT. |
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