STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER
FDA premarket approval P990013/S021 · decided 2008-07-11
Approval details
- PMA number
- P990013
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2008-06-06
- Decision date
- 2008-07-11
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- MODIFICATION TO THE BASE BLOCKING PROCESS FOR ALL COLLAMER LENSES MANUFACTURED AT THE STAAR® SURGICAL AG FACILITY.
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