BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL
FDA premarket approval P080011/S029 · decided 2014-06-03
Approval details
- PMA number
- P080011
- Supplement
- S029
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2014-02-03
- Decision date
- 2014-06-03
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL FOR NEW BRAND NAMES BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL.
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