PMA P880027S049

Device: TAKUMI OVER THE WIRE PTCA CATHETERS
Applicant: Boston Scientific
PMA number: P880027
Supplement: S049
Product code: LOX
Decision date: 1997-11-10
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for a new model PTCA catheter. The device, as modified, will be marketed under the trade name Takumi(TM) Over the Wire Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter and is 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: TAKUMI OVER THE WIRE PTCA CATHETERS
Applicant: Boston Scientific
PMA number: P880027
Supplement: S049
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1997-11-10
Decision code: APPR
Date received: 1997-05-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a new model PTCA catheter. The device, as modified, will be marketed under the trade name Takumi(TM) Over the Wire Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.