UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P970034/S011 · decided 2008-09-12
Approval details
- PMA number
- P970034
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 2008-08-13
- Decision date
- 2008-09-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- CHANGES TO THE TUMBLING PROCESS.
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