OCUCOAT HPMC VISCOELASTIC
FDA premarket approval P860047/S027 · decided 2013-01-29
Approval details
- PMA number
- P860047
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OCUCOAT HPMC VISCOELASTIC
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2012-12-31
- Decision date
- 2013-01-29
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ADDITION OF AN ALTERNATE DILUENT FOR ENDOTOXIN TESTING.
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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 |