Biofinity Sphere, Biofinity Torie, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR (comfilcon A) Soft (Hydr
FDA premarket approval P080011/S157 · decided 2023-09-28
Approval details
- PMA number
- P080011
- Supplement
- S157
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Sphere, Biofinity Torie, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR (comfilcon A) Soft (Hydr
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2023-09-01
- Decision date
- 2023-09-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Relocation of Syncro Langenpac Label Only Machine and Label Only Tray Loader (LP7 Syncro) from ground floor to the 1st Floor at the Cooper Vision Manufacturing, Ltd, Mountpark, UK Facility to produce Biofinity family lenses.
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