VANTAGE (TETRAFILCON A ) CONTACT LENS
FDA premarket approval N17679/S029 · decided 1995-07-28
Approval details
- PMA number
- N17679
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VANTAGE (TETRAFILCON A ) CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1995-03-01
- Decision date
- 1995-07-28
- Days to decision
- 149 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR REDUCTION OF THE INCUBATION TIEM OF THE BIOLOGICAL INDICATOR USED IN THE LENS STERILIZATION PROCESS TO FORTY-EIGHT HOURS.
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