MEMORY LENS MODEL U940A UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL
FDA premarket approval P960036/S001 · decided 2000-08-25
Approval details
- PMA number
- P960036
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Other
- Trade name
- MEMORY LENS MODEL U940A UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL
- Generic name
- intraocular lens
- Applicant
- Ioltech, S.A.
- Date received
- 1999-08-23
- Decision date
- 2000-08-25
- Days to decision
- 368 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Penbroke, MA
- Statement
- APPROVAL FOR A SHELF-LIFE EXTENSION TO 18 MONTHS, A PROPOSED PROTOCOL FOR ADDITIONAL SHEL-LIFE EXTENSIONS, AND A NEW DIMENSIONAL SPECIFICATION.
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