BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses
FDA premarket approval P080011/S044 · decided 2016-06-10
Approval details
- PMA number
- P080011
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2016-05-16
- Decision date
- 2016-06-10
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Validation of Line 4 at the CooperVision Inc. Hamble, UK manufacturing facility to manufacture Biofinity Energys asphere minus power (plano to -12.00D, inclusive) and plus power (+0.25D to +8.00D, inclusive) lenses within the power ranges.
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