PMA P040014S021

Device: THERAPY CATHETER (NON-IRRIGATED)
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S021
Product code: LPB
Decision date: 2014-03-21
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: APPROVAL FOR MODIFICATION TO THE CURRENTLY MARKETED 1500T9 SERIES CARDIAC ABLATION GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPERE GENERATOR AND IS INDICATED FOR: THE AMPERE GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ABLATION CATHETERS IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT CARDIAC ARRHYTHMIAS.

Current openFDA PMA Record#

Device: THERAPY CATHETER (NON-IRRIGATED)
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S021
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2014-03-21
Decision code: APPR
Date received: 2013-11-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATION TO THE CURRENTLY MARKETED 1500T9 SERIES CARDIAC ABLATION GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPERE GENERATOR AND IS INDICATED FOR: THE AMPERE GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ABLATION CATHETERS IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT CARDIAC ARRHYTHMIAS.