FDA.reportPublic FDA data

PMA P040014S045

Device
Ampere™ Generator
Applicant
Irvine Biomedical, Inc.
PMA number
P040014
Supplement
S045
Product code
LPB
Decision date
2021-10-14
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
Implement non-product software changes to the Ampere Generator and Remote Control Calibration and Functional Tests, and the Best Electrical Automated Safety Tester (BEAST) electrical test processes involved in the manufacture of Ampere Generator and Remote Control.

Current openFDA PMA Record#

Device
Ampere™ Generator
Applicant
Irvine Biomedical, Inc.
PMA number
P040014
Supplement
S045
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2021-10-14
Decision code
OK30
Date received
2021-09-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implement non-product software changes to the Ampere Generator and Remote Control Calibration and Functional Tests, and the Best Electrical Automated Safety Tester (BEAST) electrical test processes involved in the manufacture of Ampere Generator and Remote Control.