FDA.reportPublic FDA data

PMA P110016S079

Device
Ampere™ Generator
Applicant
ABBOTT MEDICAL
PMA number
P110016
Supplement
S079
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
ABBOTT MEDICAL
PMA number
P110016
Supplement
S079
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.