PMA P810046S124

Device
CHANGES TO ACS(R) SLALOM ADD 1.5 MM BALLOON SIZE
Applicant
Advanced Cardiovascular Systems, Inc.
PMA number
P810046
Supplement
S124
Product code
LOX
Decision date
1993-09-30
Classification
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Generic name
Catheters, transluminal coronary angioplasty, percutaneous

Current openFDA PMA Record#

Device
CHANGES TO ACS(R) SLALOM ADD 1.5 MM BALLOON SIZE
Applicant
Advanced Cardiovascular Systems, Inc.
PMA number
P810046
Supplement
S124
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
1993-09-30
Decision code
APPR
Date received
1992-04-23
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material