BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL
FDA premarket approval P080011/S035 · decided 2015-03-11
Approval details
- PMA number
- P080011
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2014-12-16
- Decision date
- 2015-03-11
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL FOR A CHANGE IN TRADE NAME FOR THE BIOFINITY ENERGYS ASPHERIC LENS AND EXPANDED POWERS FOR THE BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL LENSES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, AND BIOFINITY XR MULTIFOCAL (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOREXTENDED WEAR AND ARE INDICATED FOR: BIOFINITY ENERGYS ASPHERE (COMFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF AMETROPIA (MYOPIA
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