PMA P930012S009

Device: CHAMPION WRAP PTCA CATHETER
Applicant: Progressive Angioplasty Systems, Inc.
PMA number: P930012
Supplement: S009
Product code: LOX
Decision date: 1998-02-23
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for the addition of (1) quarter-size diameter balloons, including sizes of 2.5 mm, 2.75 mm, 3.25 mm, 3.75 mm, 4.25 mm, and 4.5 mm, and (2) a second radiopaque marker to all 20 mm long balloon catheters. The referenced devices 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: S009
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1998-02-23
Decision code: APPR
Date received: 1998-01-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of (1) quarter-size diameter balloons, including sizes of 2.5 mm, 2.75 mm, 3.25 mm, 3.75 mm, 4.25 mm, and 4.5 mm, and (2) a second radiopaque marker to all 20 mm long balloon catheters. The referenced devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.