SENSAR 1-PIECE LENS MODEL AAB00
FDA premarket approval P980040/S053 · decided 2014-11-15
Approval details
- PMA number
- P980040
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SENSAR 1-PIECE LENS MODEL AAB00
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2014-10-20
- Decision date
- 2014-11-15
- Days to decision
- 26 days
- Decision code
- OK30
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE FROM MACHINED TO A MOLDED IOL EDGE BLOCKER, CHANGE IN CYCLE TIME FOR THE IOL TUMBLING PROCESS, ADDITION OF A COSMETIC INSPECTION FOLLOWINGSTERILIZATION, CHANGE IN TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF IOLS, ANDNEW ULTRA HIGH PERFORMANCE LIQUID CHROMATOGRAPHY EQUIPMENT FOR TESTING RESIDUAL MONOMER LEVELS OF IOL SOFT ACRYLIC MATERIAL.
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