HYDROVIEW IOL BLANK MATERIAL
FDA premarket approval P990014/S002 · decided 2002-09-04
Approval details
- PMA number
- P990014
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- HYDROVIEW IOL BLANK MATERIAL
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2002-08-01
- Decision date
- 2002-09-04
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE TRANSFER OF THE LENS BLANK MATERIAL MANUFACTURING FACILITY TO BAUSCH & LOMB INC., WILMINGTON, MASSACHUSETTS.
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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 |