|
Device | Assurity MRI and Endurity MRI Pacemakers |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P140033 |
Supplement Number | S051 |
Date Received | 11/25/2019 |
Decision Date | 12/06/2019 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Alternate supplier for the RF antenna and ribbon carrier components used in Scalable Brady Platform SR/DR pacemakers. |