PMA P040014S025

Device: THERAPY ABLATION CATHETER INCLUDING BI-DIRECTIONAL CATHETER AND THERAPY 4MM THERNISTOR ABLATION CATHETER
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S025
Product code: LPB
Decision date: 2015-05-20
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: CHANGE IN MANUFACTURING ROOM LOCATION OF THE BAND ELECTRODE SUB-ASSEMBLY.

Current openFDA PMA Record#

Device: THERAPY ABLATION CATHETER INCLUDING BI-DIRECTIONAL CATHETER AND THERAPY 4MM THERNISTOR ABLATION CATHETER
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S025
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2015-05-20
Decision code: OK30
Date received: 2015-04-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN MANUFACTURING ROOM LOCATION OF THE BAND ELECTRODE SUB-ASSEMBLY.