PMA P810046S202
- Device
- CROSS SAIL CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S202
- Product code
- LOX
- Decision date
- 2000-11-03
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order 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.
Current openFDA PMA Record#
- Device
- CROSS SAIL CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S202
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2000-11-03
- Decision code
- OK30
- Date received
- 2000-10-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.