PMA P040042S051

Device: Ampere™ Generator
Applicant: Irvine Biomedical,Inc.(Ibi)
PMA number: P040042
Supplement: S051
Product code: OAD
Decision date: 2021-10-14
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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.(Ibi)
PMA number: P040042
Supplement: S051
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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.