CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
FDA premarket approval P030002/S003 · decided 2005-06-06
Approval details
- PMA number
- P030002
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
- Generic name
- Lens, intraocular, accommodative
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2005-05-04
- Decision date
- 2005-06-06
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT LIFE SCIENCES OUTSOURCING (LSO), BREA, CALIFORNIA.
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