PMA P040014S004

Device: THERAPY ABLATION CATHETERS
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S004
Product code: LPB
Decision date: 2007-01-10
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: APPROVAL FOR 1) THE ADDITION OF THERMISTOR TEMPERATURE SENSOR CATHETERS TO THE THERAPY CATHETER MODEL MIX, 2) THE ADDITION OF A 1763-E COMPATIBLE INTERFACE CABLE TO THE 4MM THERMISTOR ABLATION CATHETER, AND 3) THE ADDITION OF THE 1778-E COMPATIBLE INTERFACE CABLE TO THE 8MM THERMISTOR ABLATION CATHETER.

Current openFDA PMA Record#

Device: THERAPY ABLATION CATHETERS
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S004
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2007-01-10
Decision code: APPR
Date received: 2006-09-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR 1) THE ADDITION OF THERMISTOR TEMPERATURE SENSOR CATHETERS TO THE THERAPY CATHETER MODEL MIX, 2) THE ADDITION OF A 1763-E COMPATIBLE INTERFACE CABLE TO THE 4MM THERMISTOR ABLATION CATHETER, AND 3) THE ADDITION OF THE 1778-E COMPATIBLE INTERFACE CABLE TO THE 8MM THERMISTOR ABLATION CATHETER.