PMA P810046S210
- Device
- POWERSAIL/HIGHSAIL CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S210
- Product code
- LOX
- Decision date
- 2002-02-15
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR MODIFICATIONS IN MANUFACTURING PROCESS OF THE POWERSAIL AND HIGHSAIL PTCA CATHETERS.
Current openFDA PMA Record#
- Device
- POWERSAIL/HIGHSAIL CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S210
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2002-02-15
- Decision code
- APPR
- Date received
- 2001-11-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS IN MANUFACTURING PROCESS OF THE POWERSAIL AND HIGHSAIL PTCA CATHETERS.