PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P790027/S068 · decided 2003-01-27
Approval details
- PMA number
- P790027
- Supplement
- S068
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 2002-08-30
- Decision date
- 2003-01-27
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR A FACILITY CHANGE TO PRODUCE THE VIOLET COMPRESSION MOLDED (BCM) BLANK PMMA MATERIAL AT BAUSCH & LOMB, INC., WILMINGTON, MASSACHUSETTS.
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