|
Device | SYNERGYST II PULSE GENERATOR |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Medtronic, Inc. 8200 Coral Sea Street, N.E. MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S372 |
Date Received | 12/15/2016 |
Decision Date | 09/01/2017 |
Product Code |
NVZ |
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 Approval for the Heart Failure Risk Status feature for the CareLink Network. |
Post-Approval Study | Show Report Schedule and Study Progress |