EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS
FDA premarket approval P100016/S002 · decided 2015-04-13
Approval details
- PMA number
- P100016
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2014-12-18
- Decision date
- 2015-04-13
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN ONTARIO, CALIFORNIA.
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