PMA P810046S211

Device: POWERSAIL/HIGHSAIL CORONARY DILATION CATHETERS
Applicant: Advanced Cardiovascular Systems, Inc.
Product code: LOX
Decision date: 2002-02-22
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR A SINGLE PROCESS CHANGE CONCERNING THE TEMPERATURE FOR THE ACCELERATING AGING PROTOCOL FOR THE SHELF-LIFE TESTING OF THE POWERSAIL AND HIGHSAIL CORONARY DILATATION CATHETERS.

Current openFDA PMA Record#

Device: POWERSAIL/HIGHSAIL CORONARY DILATION CATHETERS
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S211
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 2002-02-22
Decision code: APPR
Date received: 2001-12-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A SINGLE PROCESS CHANGE CONCERNING THE TEMPERATURE FOR THE ACCELERATING AGING PROTOCOL FOR THE SHELF-LIFE TESTING OF THE POWERSAIL AND HIGHSAIL CORONARY DILATATION CATHETERS.