TETRAFILCON A
FDA premarket approval N17679/S034 · decided 1999-03-17
Approval details
- PMA number
- N17679
- Supplement
- S034
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TETRAFILCON A
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1999-02-23
- Decision date
- 1999-03-17
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for an alternate tinting process, In-Monomer-Tinting Process.
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