PMA P810046S089

Device
ACS(R) STACK PERFUSION(R) DISTAL FLOW COR. DIL. CA
Applicant
Advanced Cardiovascular Systems, Inc.
PMA number
P810046
Supplement
S089
Product code
LOX
Decision date
1990-09-21
Classification
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Generic name
Catheters, transluminal coronary angioplasty, percutaneous

Current openFDA PMA Record#

Device
ACS(R) STACK PERFUSION(R) DISTAL FLOW COR. DIL. CA
Applicant
Advanced Cardiovascular Systems, Inc.
PMA number
P810046
Supplement
S089
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
1990-09-21
Decision code
APPR
Date received
1990-06-15
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename