CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS
FDA premarket approval P960036/S007 · decided 2002-07-26
Approval details
- PMA number
- P960036
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Ioltech, S.A.
- Date received
- 2002-07-08
- Decision date
- 2002-07-26
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Penbroke, MA
- Statement
- ADDITION OF AN ALTERNATE STEAM STERILIZER FOR THE TERMINAL STERILIZATION OF THE CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS.
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