PMA P870036S037
- Device
- VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM MEDTRONIC 18K, 18K WITH TIP MARKER, 14K, 14K LONG, PANTHER 30 AND 40
- Applicant
- Medtronics Interventional Vascular
- PMA number
- P870036
- Supplement
- S037
- Product code
- LOX
- Decision date
- 1995-12-07
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR THE USE OF AN ALTERNATE ADHESIVE ON HTE REFERENCED PTCA CATHETERS (VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM - MEDTRONIC 18K, 18K WITH TIP MARKER, 14K, 14K LONG, PANTHER, PANTHER 30, AND PANTHER 40 PTCA CATHETERS)
Current openFDA PMA Record#
- Device
- VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM MEDTRONIC 18K, 18K WITH TIP MARKER, 14K, 14K LONG, PANTHER 30 AND 40
- Applicant
- Medtronics Interventional Vascular
- PMA number
- P870036
- Supplement
- S037
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1995-12-07
- Decision code
- APPR
- Date received
- 1995-11-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF AN ALTERNATE ADHESIVE ON HTE REFERENCED PTCA CATHETERS (VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM - MEDTRONIC 18K, 18K WITH TIP MARKER, 14K, 14K LONG, PANTHER, PANTHER 30, AND PANTHER 40 PTCA CATHETERS)