CROSS SAIL CORONARY DILATATION CATHETER
FDA premarket approval P810046/S202 · decided 2000-11-03
Approval details
- PMA number
- P810046
- Supplement
- S202
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CROSS SAIL CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2000-10-16
- Decision date
- 2000-11-03
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- MODIFICATIONS AS FOLLOWS: 1) MODIFY THE TROUBLESHOOTING PROCESS DESCRIBING HOW TO RELEASE THE TUBING FORM A MOLD; 2) MODIFY THE SET-UP/CLEANING PROCESS PRIOR TO JOINING THE DEVICE AT THE MOD-LAP JOINT; 3) MODIFY THE SET-UP PROCESS PRIOR TO PLASMA TREATING THE DEVICE.
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