|
Device | Assurity MRI, Endurity MRI |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P140033 |
Supplement Number | S016 |
Date Received | 10/10/2017 |
Decision Date | 11/08/2017 |
Product Code |
DXY |
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 Updates to manufacturing operator procedures and operator retraining. |