BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES-THERAPEUTIC USE
FDA premarket approval P980006/S007 · decided 2005-05-27
Approval details
- PMA number
- P980006
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES-THERAPEUTIC USE
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2005-03-03
- Decision date
- 2005-05-27
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR ADDING A THERAPEUTIC INDICATION FOR THE PUREVISION CONTACT LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS FOR THERAPEUTIC USE AND IS INDICATED FOR THERAPEUTIC USE AS A BANDAGE CONTACT LENS FOR CORNEAL PROTECTION AND CORNEAL PAIN RELIEF DURING TREATMENT OF OCULAR PATHOLOGIES AS WELL AS POST-SURGICAL CONDITIONS. APPLICATIONS OF THE PUREVISION CONTACT LENS INCLUDE BUT ARE NOT LIMITED TO CONDITI
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