- Device
- SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S416
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2020-04-23
- Decision code
- APPR
- Date received
- 2019-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Cobalt XT, Cobalt, and Crome MRI SureScan Implantable Cardioverter Defibrillator (ICD) and ICD with Cardiac Resynchronization Systems.