STAAR SURGICAL COLLAMER INTRAOCULAR LENSES
FDA premarket approval P990013/S031 · decided 2011-05-04
Approval details
- PMA number
- P990013
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAAR SURGICAL COLLAMER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2011-03-30
- Decision date
- 2011-05-04
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- MODIFICATION TO THE BLOCKING PROCESS FOR THE MANUFACTURE OF THE PRODUCT LINES.
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