PMA P040014S007

Device
THERAPY CARDIAC ABLATION CATHETERS
Applicant
Irvine Biomedical, Inc.
PMA number
P040014
Supplement
S007
Product code
LPB
Decision date
2008-06-09
Classification
Cardiac Ablation Percutaneous Catheter
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
ADDITIONAL SUPPLIERS FOR THE DEVICE.

Current openFDA PMA Record#

Device
THERAPY CARDIAC ABLATION CATHETERS
Applicant
Irvine Biomedical, Inc.
PMA number
P040014
Supplement
S007
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2008-06-09
Decision code
OK30
Date received
2008-05-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITIONAL SUPPLIERS FOR THE DEVICE.