FDA.reportPublic FDA data

PMA P130026S076

Device
Ampere™ Generator
Applicant
St Jude Medical
PMA number
P130026
Supplement
S076
Product code
OAE
Decision date
2021-10-14
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
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
St Jude Medical
PMA number
P130026
Supplement
S076
Product code
OAE
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
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.