POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENS
FDA premarket approval P850059/S016 · decided 1996-05-01
Approval details
- PMA number
- P850059
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb Surgical, Inc.
- Date received
- 1995-10-31
- Decision date
- 1996-05-01
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL OF THE FOLLOWING:IMPLEMENTATION OF NEW MANUFACTURING PROCESSES OF CLEAR AND VIOLET HAPTIC POLYMETHYLMETHACRYLATE (PMMA) ONE-PIECE POSTERIOR CHAMBER LENSES; THE USE OF A NEW TUMBLING PROCESS FOR YOUR THREE-PIECE LENSES; AND THE INTRODUCTION OF SEVERAL TIER A POSTERIOR CHAMBER LENSES, MODELS 8192B, 8490B, 8492B, 8090B, 8091B, 8193B, 8491B, 8493B, 8491B, 8493B, 8990B, 8991B, 8093B, 8095B, 8195B, AND 8594B
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