STAAR SURGICAL COLLAMER UV-ABSORBING PC INTRAOCULAR LENS
FDA premarket approval P990013/S018 · decided 2009-04-02
Approval details
- PMA number
- P990013
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAAR SURGICAL COLLAMER UV-ABSORBING PC INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2008-04-02
- Decision date
- 2009-04-02
- Days to decision
- 365 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- APPROVAL FOR A CHANGE IN STOPPER MATERIAL FOR THE DEVICE.
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