PMA P040014S011

Device
THERAPY CARDIAC ABLATION CATHETER
Applicant
Irvine Biomedical, Inc.
PMA number
P040014
Supplement
S011
Product code
LPB
Decision date
2009-08-28
Classification
Cardiac Ablation Percutaneous Catheter
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
CHANGE IN THE PROXIMAL COMPONENT OF THE ABLATION CATHETERS.

Current openFDA PMA Record#

Device
THERAPY CARDIAC ABLATION CATHETER
Applicant
Irvine Biomedical, Inc.
PMA number
P040014
Supplement
S011
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2009-08-28
Decision code
OK30
Date received
2009-07-30
Supplement type
30-Day Notice
Approval order statement
CHANGE IN THE PROXIMAL COMPONENT OF THE ABLATION CATHETERS.