STARR COLLAMER (TM) UV ABSORBING PC IOL
FDA premarket approval P990013/S003 · decided 2001-07-20
Approval details
- PMA number
- P990013
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STARR COLLAMER (TM) UV ABSORBING PC IOL
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2001-07-06
- Decision date
- 2001-07-20
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- CHANGE OF MANUFACTURING METHOD FOR STAAR COLLAMER(TM) INTRAOCULAR LENSES THAT INVOLVES THE ADDITION OF A SECONDARY CHROMOPHORE PURIFICATION PROCESS.
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