PMA P040014S016

Device: THERAPY/THERAPY BI-DIRECTIONAL/THERAPY 4MM THERMISTOR ABLATION CATHETERS
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S016
Product code: LPB
Decision date: 2011-02-17
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: IMPLEMENT AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.IMPLEMENTATION OF AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.

Current openFDA PMA Record#

Device: THERAPY/THERAPY BI-DIRECTIONAL/THERAPY 4MM THERMISTOR ABLATION CATHETERS
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S016
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2011-02-17
Decision code: OK30
Date received: 2011-01-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENT AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.IMPLEMENTATION OF AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.