ANTERIOR CHAMBER IOL'S
FDA premarket approval P850059/S019 · decided 1999-01-28
Approval details
- PMA number
- P850059
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANTERIOR CHAMBER IOL'S
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb Surgical, Inc.
- Date received
- 1998-12-23
- Decision date
- 1999-01-28
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Approval for an alternate packaging configuration for the PMMA IOLs, manufactured at Claremont, CA facility.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.