BAUSCH & LOMB PUREVISION/PUREVISION 2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES
FDA premarket approval P980006/S014 · decided 2009-05-05
Approval details
- PMA number
- P980006
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BAUSCH & LOMB PUREVISION/PUREVISION 2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2008-11-12
- Decision date
- 2009-05-05
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR THE USE OF AN ALTERNATE RESIN SUNOCO D-115A TO FORM THE BLISTER PACKAGE CONTAINER FOR THE DEVICE.
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| BAUSCH & LOMB IOL INJECTOR (K113852) | Bausch & Lomb, Inc. | 2012-09-28 |
| OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION (K112909) | Bausch & Lomb, Inc. | 2012-04-30 |
| EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION (K111877) | Bausch & Lomb, Inc. | 2012-01-24 |