COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P990013/S015 · decided 2008-03-21
Approval details
- PMA number
- P990013
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2008-02-22
- Decision date
- 2008-03-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- IMPLEMENTATION OF NEW SEMI-AUTOMATED PRODUCTION EQUIPMENT FOR THE BLOCKING PROCESS.
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