PMA P870036S044

Device: THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER
Applicant: Medtronics Interventional Vascular
PMA number: P870036
Supplement: S044
Product code: LOX
Decision date: 1998-11-17
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for a new product line. The device, as modified, will be marketed under the trade name Medtronic(R) Achiever(TM) Coronary Balloon Dilatation Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Current openFDA PMA Record#

Device: THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER
Applicant: Medtronics Interventional Vascular
PMA number: P870036
Supplement: S044
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1998-11-17
Decision code: APPR
Date received: 1998-05-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a new product line. The device, as modified, will be marketed under the trade name Medtronic(R) Achiever(TM) Coronary Balloon Dilatation Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.