Synergyst II Pulse Generator
FDA premarket approval P890003/S425 · decided 2020-03-02
Approval details
- PMA number
- P890003
- Supplement
- S425
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Synergyst II Pulse Generator
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2019-12-23
- Decision date
- 2020-03-02
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for firmware updates to the MyCareLink Patient Monitor Models 24950 and 24952.
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