BIOFINILITY (COMFILCON A) SOFT (HYDROPHYLIC) EXTENDED-WEAR CONTACT LENSES
FDA premarket approval P080011/S016 · decided 2012-07-17
Approval details
- PMA number
- P080011
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINILITY (COMFILCON A) SOFT (HYDROPHYLIC) EXTENDED-WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2012-06-25
- Decision date
- 2012-07-17
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- REQUALIFICATION OF MANUFACTURING EQUIPMENT.
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