|
Device | Assurity MRI and Endurity MRI |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P140033 |
Supplement Number | S060 |
Date Received | 09/29/2020 |
Decision Date | 12/16/2020 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for 3T MR Conditional labeling of certain Assurity MRI and Endurity MRI models when combined with a subset (46 cm, 52 cm and 58 cm) of Tendril STS Model 2088TC leads. |