PMA P810046S212
- Device
- HIGHSAIL CORONARY DILATATION CATHETERS
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S212
- Product code
- DYG
- Decision date
- 2002-05-10
- Classification
- Catheter, Flow Directed
- Generic name
- CATHETER, FLOW DIRECTED
- Approval order statement
- APPROVAL TO MODIFY THE PACKAGING BY ELIMINATING THE FLUSHING TOOL AND REPLACING THE DISPENSER TUBING COIL.
Current openFDA PMA Record#
- Device
- HIGHSAIL CORONARY DILATATION CATHETERS
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S212
- Product code
- DYG
- Generic name
- CATHETER, FLOW DIRECTED
- Decision date
- 2002-05-10
- Decision code
- APPR
- Date received
- 2002-03-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO MODIFY THE PACKAGING BY ELIMINATING THE FLUSHING TOOL AND REPLACING THE DISPENSER TUBING COIL.