ANTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P010027/S004 · decided 2012-03-02
Approval details
- PMA number
- P010027
- Supplement
- S004
- Supplement type
- 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
- 2012-02-02
- Decision date
- 2012-03-02
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- ALTERNATE VENDOR TO PERFORM LIMULUS AMEBOCYTE LYSATE (LAL) TESTING.
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