UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P970034/S013 · decided 2009-11-13
Approval details
- PMA number
- P970034
- Supplement
- S013
- 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
- 2009-10-09
- Decision date
- 2009-11-13
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- ACQUISITION OF ONE PIECE OF EQUIPMENT AND THE ADDITION OF A TEST FACILITY.
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