PMA P930012S010

Device: CHAMPION WRAP PTCA CATHETER
Applicant: Progressive Angioplasty Systems, Inc.
PMA number: P930012
Supplement: S010
Product code: LOX
Decision date: 1998-06-15
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for 1) a change in trade names for the Champion(TM) HP PTCA Catheters and Champion(TM) HP PTCA Catheters with Wrap(TM) Sheathing System previously approved under PMA supplements 5, 8, and 9, and 2) a reduction in the wall thickness of the 3.5 mm and 4.0 mm diameter balloons used in these designs. the devices, as modified, will be marketed under the trde names Champion(TM) NC PTCA Catheter and Wrap(TM) NC PTCA Catheter, and are 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: CHAMPION WRAP PTCA CATHETER
Applicant: Progressive Angioplasty Systems, Inc.
PMA number: P930012
Supplement: S010
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1998-06-15
Decision code: APPR
Date received: 1998-05-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for 1) a change in trade names for the Champion(TM) HP PTCA Catheters and Champion(TM) HP PTCA Catheters with Wrap(TM) Sheathing System previously approved under PMA supplements 5, 8, and 9, and 2) a reduction in the wall thickness of the 3.5 mm and 4.0 mm diameter balloons used in these designs. the devices, as modified, will be marketed under the trde names Champion(TM) NC PTCA Catheter and Wrap(TM) NC PTCA Catheter, and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.