BIOFINITY ENERGY ASPHERE
FDA premarket approval P080011/S046 · decided 2016-10-05
Approval details
- PMA number
- P080011
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINITY ENERGY ASPHERE
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2016-09-13
- Decision date
- 2016-10-05
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Validation of Biofinity Line 17 at the CooperVision Inc. Hamble, UK manufacturing facility to produce Biofinity Energys Asphere plus power lenses (+0.25D to +8.00D).
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