PMA P930012S008

Device: CHAMPION WRAP PTCA CATHETER
Applicant: Progressive Angioplasty Systems, Inc.
PMA number: P930012
Supplement: S008
Product code: LOX
Decision date: 1998-02-02
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for: 1) a line of Champion(TM) HP PTCA Catheters packaged with the Wrap(TM) Sheathing System; 2) the additionof quarter-sized balloons to this line of catheters extending the balloon diameter limits from 3.0-4.0 mm to 2.5-4.5mm; and 3) a revised package insert which streamlines the Instructions for Use and compresses the previous package inserts for the 15 mm and 20 mm long balloons into one combined insert.

Current openFDA PMA Record#

Device: CHAMPION WRAP PTCA CATHETER
Applicant: Progressive Angioplasty Systems, Inc.
PMA number: P930012
Supplement: S008
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1998-02-02
Decision code: APPR
Date received: 1997-08-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for: 1) a line of Champion(TM) HP PTCA Catheters packaged with the Wrap(TM) Sheathing System; 2) the additionof quarter-sized balloons to this line of catheters extending the balloon diameter limits from 3.0-4.0 mm to 2.5-4.5mm; and 3) a revised package insert which streamlines the Instructions for Use and compresses the previous package inserts for the 15 mm and 20 mm long balloons into one combined insert.