PMA P930012S012

Device: LACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE
Applicant: Progressive Angioplasty Systems, Inc.
PMA number: P930012
Supplement: S012
Product code: LOX
Decision date: 1998-08-25
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for a change in labeling for the LaCrosse(TM) PTCA and Champion(TM) PTCA Catheter Product Lines. Specifically, the change included a reduction in the labeled rated burst pressures for the 2.5mmx20mm, 3.0mmx30mm, and 3.5mmx30mm LaCrosse(TM) PTCA Catheters and the 2.0mmx20mm Champion(TM) PTCA Catheter.

Current openFDA PMA Record#

Device: LACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE
Applicant: Progressive Angioplasty Systems, Inc.
PMA number: P930012
Supplement: S012
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1998-08-25
Decision code: APPR
Date received: 1998-07-24
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a change in labeling for the LaCrosse(TM) PTCA and Champion(TM) PTCA Catheter Product Lines. Specifically, the change included a reduction in the labeled rated burst pressures for the 2.5mmx20mm, 3.0mmx30mm, and 3.5mmx30mm LaCrosse(TM) PTCA Catheters and the 2.0mmx20mm Champion(TM) PTCA Catheter.