FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Pulse Generator, Permanent, Implantable
PMA: P980035
·
Supplement: S838
·
Decision Mar 27, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Pulse Generator, Permanent, Implantable
- Trade Name
- Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG
- PMA Number
- P980035
- Supplement Number
- S838
- Device Class
- FDA Class 3
- Product Code
- NVZ
- Generic Name
- Pulse generator, permanent, implantable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 27, 2026
- Date Received
- March 10, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
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 |