PMA P810046S117

Device
ACS CORONARY DILATATION CATHETERS
Applicant
Advanced Cardiovascular Systems, Inc.
PMA number
P810046
Supplement
S117
Product code
LOX
Decision date
1992-04-09
Generic name
Catheters, transluminal coronary angioplasty, percutaneous

Current openFDA PMA Record#

Device
ACS CORONARY DILATATION CATHETERS
Applicant
Advanced Cardiovascular Systems, Inc.
PMA number
P810046
Supplement
S117
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
1992-04-09
Decision code
APPR
Date received
1991-12-23
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename