OCUCOAT OVD
FDA premarket approval P860047/S029 · decided 2015-03-03
Approval details
- PMA number
- P860047
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OCUCOAT OVD
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2014-12-24
- Decision date
- 2015-03-03
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO REPLACE THE 25 GAUGE CANNULA THAT IS PACKAGED WITH THE1 ML OCUCOAT PRODUCT WITH A 23 GAUGE CANNULA.
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| BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, (K131208) | Bausch & Lomb, Inc. | 2013-09-11 |
| BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI (K122575) | Bausch & Lomb, Inc. | 2012-12-20 |
| 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 |