PMMA INTRAOCULAR LENS
FDA premarket approval P790027/S067 · decided 2002-05-21
Approval details
- PMA number
- P790027
- Supplement
- S067
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- PMMA INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 2002-04-08
- Decision date
- 2002-05-21
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT BAUSCH & LOMB, INC. WILMINGTON, MASSACHUSETTS. THE CLEAR COMPRESSION MOLDED BLANK PMMA MATERIAL WILL BE MANUFACTURED AT THIS FACILITY.
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| STELLARIS VISION ENHANCEMENT SYSTEM (K133242) | Bausch & Lomb | 2014-02-14 |
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| CRYSTALSERT DELIVERY SYSTEM (K132593) | Bausch & Lomb | 2013-09-17 |