|
Device | Ampere™ Generator, Ampere™ Remote Control, Ampere™ Generator System Kit |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S090 |
Date Received | 06/02/2023 |
Decision Date | 11/29/2023 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement design and labeling changes to the Ampere Generator and associated equipment |