PUREVISION (BALAFILCON A) CONTACT LENS
FDA premarket approval P980006/S018 · decided 2014-06-03
Approval details
- PMA number
- P980006
- Supplement
- S018
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- PUREVISION (BALAFILCON A) CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2010-12-03
- Decision date
- 2014-06-03
- Days to decision
- 1278 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR THE REVISION OF THE LABELING FOR THE PUREVISIONĀ® (BALAFILCON A)CONTACT LENS TO INCLUDE THE RESULTS OF THE POST-APPROVAL STUDY.
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