PMA P910031S015

Device: ORACLE MEGASONICS FIVE-64 PTCA CATHETER
Applicant: Abbott Vascular Devices
PMA number: P910031
Supplement: S015
Product code: LOX
Decision date: 1998-05-01
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for Oracle MegaSonics Five-64(TM) PTCA Catheter. The device, as modified, will be marketed under the trade name Oracle MegaSonics Five-64(TM) PTCA Catheter and is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts for the purpose of improving myocardial perfusion. The catheter is further indicated for use following balloon dilatation as an adjunct to conventional angiographic procedures to provide: 1) an image of the vessel lumen and wall structures and 2) dimensional measurements from the image.

Current openFDA PMA Record#

Device: ORACLE MEGASONICS FIVE-64 PTCA CATHETER
Applicant: Abbott Vascular Devices
PMA number: P910031
Supplement: S015
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1998-05-01
Decision code: APPR
Date received: 1997-03-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for Oracle MegaSonics Five-64(TM) PTCA Catheter. The device, as modified, will be marketed under the trade name Oracle MegaSonics Five-64(TM) PTCA Catheter and is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts for the purpose of improving myocardial perfusion. The catheter is further indicated for use following balloon dilatation as an adjunct to conventional angiographic procedures to provide: 1) an image of the vessel lumen and wall structures and 2) dimensional measurements from the image.