PMA P040014S022

Device: THERAPY CATHETER (NON-IRRIGATED)
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S022
Product code: LPB
Decision date: 2014-04-28
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: APPROVAL FOR CHANGES TO THERMAL AND EGM BOARDS, UPGRADE TO THE FIRMWARE AND SOFTWARE, ADDITION OF REMOTE CONTROL FIBER CORD LENGTHS AND UPDATES TO THE INSTRUCTION FOR USE OF THE AMPERE GENERATOR.

Current openFDA PMA Record#

Device: THERAPY CATHETER (NON-IRRIGATED)
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S022
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2014-04-28
Decision code: APPR
Date received: 2014-03-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THERMAL AND EGM BOARDS, UPGRADE TO THE FIRMWARE AND SOFTWARE, ADDITION OF REMOTE CONTROL FIBER CORD LENGTHS AND UPDATES TO THE INSTRUCTION FOR USE OF THE AMPERE GENERATOR.