STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P990013/S022 · decided 2008-09-10
Approval details
- PMA number
- P990013
- Supplement
- S022
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2008-07-23
- Decision date
- 2008-09-10
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- APPROVAL FOR ADDING IN HOUSE LIMULUS AMEBOCYTE LYSATE TESTING.
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