PMA P870036S036
- Device
- VERSAFLEX; BUCHBINDER, OMNIFLEX PTCA CATHETER SYSTEMS MEDTRONIC 18K, 14K, EVERGREEN, FALCON, PANTHER, AND SPIRIT PTCAR
- Applicant
- Medtronics Interventional Vascular
- PMA number
- P870036
- Supplement
- S036
- Product code
- LOX
- Decision date
- 1996-04-08
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- REVISED LABELING
Current openFDA PMA Record#
- Device
- VERSAFLEX; BUCHBINDER, OMNIFLEX PTCA CATHETER SYSTEMS MEDTRONIC 18K, 14K, EVERGREEN, FALCON, PANTHER, AND SPIRIT PTCAR
- Applicant
- Medtronics Interventional Vascular
- PMA number
- P870036
- Supplement
- S036
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-04-08
- Decision code
- APPR
- Date received
- 1995-07-17
- Supplement type
- Normal 180 Day Track
- Approval order statement
- REVISED LABELING