PMA P790017S077
- Device
- STORMER ZIPPER MX BALLOON DILATATION CATHETER
- Applicant
- Medtronic, Ireland
- PMA number
- P790017
- Supplement
- S077
- Product code
- LOX
- Decision date
- 2002-09-18
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR THE STORMER BALLOON DILATATION CATHETER WITH ZIPPER DELIVERY, WHICH IS INDICATED FOR BALLOON DILATATION OF THE STENOIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
Current openFDA PMA Record#
- Device
- STORMER ZIPPER MX BALLOON DILATATION CATHETER
- Applicant
- Medtronic, Ireland
- PMA number
- P790017
- Supplement
- S077
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2002-09-18
- Decision code
- APPR
- Date received
- 2002-04-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE STORMER BALLOON DILATATION CATHETER WITH ZIPPER DELIVERY, WHICH IS INDICATED FOR BALLOON DILATATION OF THE STENOIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.