Biofinity XR Toric
FDA premarket approval P080011/S060 · decided 2017-06-22
Approval details
- PMA number
- P080011
- Supplement
- S060
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity XR Toric
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2017-05-26
- Decision date
- 2017-06-22
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Modification to the surface finish of the male plug used in the manufacturing of Biofinity MTO (Made to Order) XR Toric lenses.
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