TETRAFILCON A
FDA premarket approval N17679/S035 · decided 2011-04-29
Approval details
- PMA number
- N17679
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TETRAFILCON A
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2011-03-24
- Decision date
- 2011-04-29
- Days to decision
- 36 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- 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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