BIOFINITY (COMFLICON A) SOFT (HYDROPHILIC) CONTACT LENSES
FDA premarket approval P080011/S032 · decided 2014-12-17
Approval details
- PMA number
- P080011
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINITY (COMFLICON A) SOFT (HYDROPHILIC) CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2014-11-03
- Decision date
- 2014-12-17
- Days to decision
- 44 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL FOR THE USE OF AN ALTERNATE PICK HEAD MATERIAL, FOR THE MANUFACTURE OF COMFILCON A EXTENDED-WEAR CONTACT LENSES.
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