PMA P810046S179

Device: ACS RX ROCKET TM AND ACS AVENGER CORONARY DILATATION CAHTETERS
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S179
Product code: LOX
Decision date: 1997-11-07
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for the ACS RX Rocket(TM) and ACS Avenger(TM) Coronary Dilatation Catheters. The device is indicated for: 1)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for ht epurpose of improving myocardial perfusion; and 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with S-T segment elevation myocardial infarction.

Current openFDA PMA Record#

Device: ACS RX ROCKET TM AND ACS AVENGER CORONARY DILATATION CAHTETERS
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S179
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1997-11-07
Decision code: APPR
Date received: 1997-06-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the ACS RX Rocket(TM) and ACS Avenger(TM) Coronary Dilatation Catheters. The device is indicated for: 1)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for ht epurpose of improving myocardial perfusion; and 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with S-T segment elevation myocardial infarction.