- Device
- MEDTRONIC(R) FALCON(R) CORONARY BALLOON DILATATION CATHETERS
- Applicant
- Medtronics Interventional Vascular
- PMA number
- P870036
- Supplement
- S040
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-10-25
- Decision code
- APPR
- Date received
- 1996-09-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE QUALITY CONTROL PROCEDURES FOR THE MEDTRONIC(R) FALCON(R) FAMILY OF CORONARY BALLOON DILATATION CATHETERS