UV-PMMA PCLS
FDA premarket approval P970034/S002 · decided 1999-01-12
Approval details
- PMA number
- P970034
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UV-PMMA PCLS
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 1998-12-21
- Decision date
- 1999-01-12
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Approval for a packaging facility located at 1501 W. 9th Street, Suite D, Upland, CA 91785.
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