PMA P890003S481

Device: SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071
Applicant: Medtronic, Inc.
PMA number: P890003
Supplement: S481
Product code: NVZ
Decision date: 2025-10-30
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: Approval for updated labeling to include results from the post approval study (PAS) Heart Failure Risk Status (HFRS) PAS, as summarized in the final report P890003/R098.

Current openFDA PMA Record#

Device: SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071
Applicant: Medtronic, Inc.
PMA number: P890003
Supplement: S481
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2025-10-30
Decision code: APPR
Date received: 2025-07-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for updated labeling to include results from the post approval study (PAS) Heart Failure Risk Status (HFRS) PAS, as summarized in the final report P890003/R098.