SENSAR ACRYLIC INTRAOCULAR LENSES (IOLS)
FDA premarket approval P980040/S014 · decided 2007-04-26
Approval details
- PMA number
- P980040
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SENSAR ACRYLIC INTRAOCULAR LENSES (IOLS)
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2007-03-28
- Decision date
- 2007-04-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE IN THE 100% IN-PROCESS DIMENSIONAL INSPECTION STEP FOR ALL SOFT ACRYLIC INTRAOCULAR LENSES.
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