COLLAMER UV-ABSORBING POSTERIOR CHAMBER IOL
FDA premarket approval P990013/S029 · decided 2010-09-16
Approval details
- PMA number
- P990013
- Supplement
- S029
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COLLAMER UV-ABSORBING POSTERIOR CHAMBER IOL
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2010-08-17
- Decision date
- 2010-09-16
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- APPROVAL FOR MODIFICATION TO THE DIRECTIONS FOR USE TO COMPLY WITH THE LATEST MEDICAL DEVICE DIRECTIVE (MDD) 93/42/EEC.
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