PMA P810046S129

Device
ACS RX STREAK (TM) & FLOWTRACK DILATION CATHETERS
Applicant
Advanced Cardiovascular Systems, Inc.
PMA number
P810046
Supplement
S129
Product code
LOX
Decision date
1993-02-11
Classification
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Generic name
Catheters, transluminal coronary angioplasty, percutaneous

Current openFDA PMA Record#

Device
ACS RX STREAK (TM) & FLOWTRACK DILATION CATHETERS
Applicant
Advanced Cardiovascular Systems, Inc.
PMA number
P810046
Supplement
S129
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
1993-02-11
Decision code
APPR
Date received
1992-07-24
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material