STAAR SURGICAL COLLAMER INTRAOCULAR LENSES
FDA premarket approval P990013/S013 · decided 2008-09-26
Approval details
- PMA number
- P990013
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- STAAR SURGICAL COLLAMER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2007-05-04
- Decision date
- 2008-09-26
- Days to decision
- 511 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- APPROVAL FOR CHANGES TO THE LABELING.
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