ANTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P010027/S003 · decided 2010-03-12
Approval details
- PMA number
- P010027
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 2009-10-28
- Decision date
- 2010-03-12
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- APPROVAL FOR PARAMETER CHANGES IN THE STERILIZATION CYCLE.
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