BIOFINITY (COMFILCON A) SOFT (HYDROPHILLIC) EXTENDED-WEAR CONTACT LENSES
FDA premarket approval P080011/S031 · decided 2014-09-09
Approval details
- PMA number
- P080011
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINITY (COMFILCON A) SOFT (HYDROPHILLIC) EXTENDED-WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2014-08-08
- Decision date
- 2014-09-09
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- REPLACEMENT OF THE FEDEGARI THERMA 3 FOAF3 AUTOCLAVE (FEDEGARI W) WITH THERMA 4 FOAF3/A FEDEGARI AUTOCLAVE (FEDEGARI F).
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