COOPERVISION COMFILCON A SOFT EXTENDED WEAR CONTACT LENSES
FDA premarket approval P080011/S015 · decided 2012-12-18
Approval details
- PMA number
- P080011
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COOPERVISION COMFILCON A SOFT EXTENDED WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2012-06-21
- Decision date
- 2012-12-18
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL FOR THE ADDITION OF A NEW PRIVATE LABEL BRAND NAME BREATHABLES XW.
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