COLLAMER(TM) ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
FDA premarket approval P990013/S001 · decided 2000-09-25
Approval details
- PMA number
- P990013
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLAMER(TM) ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2000-07-24
- Decision date
- 2000-09-25
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY AT STAAR SURGICAL CO., MONROVIA, CALIFORNIA.
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