- Device
- POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES
- Applicant
- Bausch & Lomb
- PMA number
- P790027
- Supplement
- S059
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 1996-05-01
- Decision code
- APPR
- Date received
- 1995-10-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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, 8990B, 8991B, 8093B, 8095B, 8195B, AND 8594B.