PC-IOL
FDA premarket approval P970034/S007 · decided 2001-01-17
Approval details
- PMA number
- P970034
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PC-IOL
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 2000-07-06
- Decision date
- 2001-01-17
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT OPHTHALMIC INNOVATIONS INTERNATIONAL, INC., ONTARIO, CALIFORNIA.
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