- Device
- MEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS
- Applicant
- Medtronics Interventional Vascular
- PMA number
- P870036
- Supplement
- S039
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-08-30
- Decision code
- APPR
- Date received
- 1996-06-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR NEW BALLOON SIZES TO BE ADDED TO THE FALCON 20 CORONARY BALLOON DILATATION CATHETER LINE AND THE ADDTION OF THE FALCON 30 AND FALCON 40 COROANRY BALLOON DILATATION CATHETER LINES. ALSO, SPECIFICATION AND QUALITY CONTROL INSPECTION CHANGES WERE REQUESTED