|
Device | Ampere™ Generator |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S088 |
Date Received | 09/14/2021 |
Decision Date | 10/14/2021 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |