PMA P910031S011

Device: FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS
Applicant: Abbott Vascular Devices
PMA number: P910031
Supplement: S011
Product code: LOX
Decision date: 1997-04-09
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR THE FOLLOWING: 1) A CHANGE IN THE BALLOON DESIGN FROM A DOUBLE LAYER OF POLYETHYLENE WITH A POLYETHYLENE TEREPHALATE CENTER REGION TO A SINGLE LAYER OF POLYETHYLENE TEREPHALATE; 2) A CHANGE IN CATHETER SHAFT MATERIAL FROM POLYETHYLENE TO NYLON; 3) A CHANGE IN THE INTERNAL SHAFT DESIGN FROM A TWO LUMEN SIDE BY SIDE DESIGN TO A TWO LUMEN COAXIAL DESIGN; 4) A CHANGE IN THE BALLOON/SHAFT BONDING METHOD FROM HEAT SEALING TO A URETHANE ADHESIVE; 5) A CHANGE IN THE BALLOON LENGTHS FROM 25 MM TO 22 MM AND FROM 20 MM TO 18 MM; AND 6) A CHANGE IN THE COLOR OF THE CATHETER SHAFT FROM BLUE TO TEAL.

Current openFDA PMA Record#

Device: FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS
Applicant: Abbott Vascular Devices
PMA number: P910031
Supplement: S011
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1997-04-09
Decision code: APPR
Date received: 1996-08-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FOLLOWING: 1) A CHANGE IN THE BALLOON DESIGN FROM A DOUBLE LAYER OF POLYETHYLENE WITH A POLYETHYLENE TEREPHALATE CENTER REGION TO A SINGLE LAYER OF POLYETHYLENE TEREPHALATE; 2) A CHANGE IN CATHETER SHAFT MATERIAL FROM POLYETHYLENE TO NYLON; 3) A CHANGE IN THE INTERNAL SHAFT DESIGN FROM A TWO LUMEN SIDE BY SIDE DESIGN TO A TWO LUMEN COAXIAL DESIGN; 4) A CHANGE IN THE BALLOON/SHAFT BONDING METHOD FROM HEAT SEALING TO A URETHANE ADHESIVE; 5) A CHANGE IN THE BALLOON LENGTHS FROM 25 MM TO 22 MM AND FROM 20 MM TO 18 MM; AND 6) A CHANGE IN THE COLOR OF THE CATHETER SHAFT FROM BLUE TO TEAL.