SENSAR ACRYLIC IOLS
FDA premarket approval P980040/S018 · decided 2007-10-24
Approval details
- PMA number
- P980040
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SENSAR ACRYLIC IOLS
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2007-09-24
- Decision date
- 2007-10-24
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- INCREASE IN THE FREQUENCY OF MICROBIOLOGICAL MONITORING FOR THE WATER SYSTEM IN THE ADVANCED MEDICAL OPTICS (AMO) ANASCO, PUERTO RICO FACILITY.
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