SURGICAL COLLAMER UV-ABSORBING POSTERIOR IOL
FDA premarket approval P990013/S009 · decided 2007-05-01
Approval details
- PMA number
- P990013
- Supplement
- S009
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICAL COLLAMER UV-ABSORBING POSTERIOR IOL
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2007-02-23
- Decision date
- 2007-05-01
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- APPROVAL FOR IMPLEMENTATION OF THE IN-PROCESS BURST TESTING OF POUCHES USED ON THE COLLAMER IOLS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.