UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P970034/S010 · decided 2008-04-17
Approval details
- PMA number
- P970034
- Supplement
- S010
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 2007-12-20
- Decision date
- 2008-04-17
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- APPROVAL FOR A CHANGE IN LENS POLISH.
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