FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Pulse Generator, Permanent, Implantable
PMA: P890003
·
Supplement: S481
·
Decision Oct 30, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Pulse Generator, Permanent, Implantable
- Trade Name
- SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071
- PMA Number
- P890003
- Supplement Number
- S481
- Device Class
- FDA Class 3
- Product Code
- NVZ
- Generic Name
- Pulse generator, permanent, implantable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 30, 2025
- Date Received
- July 10, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NVZ | Pulse Generator, Permanent, Implantable | FDA class 3 | Unknown |