MEMORYLENS MODEL U940A UV-ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL
FDA premarket approval P960036/S005 · decided 2002-05-23
Approval details
- PMA number
- P960036
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEMORYLENS MODEL U940A UV-ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL
- Generic name
- intraocular lens
- Applicant
- Ioltech, S.A.
- Date received
- 2001-12-21
- Decision date
- 2002-05-23
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Penbroke, MA
- Statement
- APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESSES FOR THE MEMORYLENS IOL.
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