FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Dorsal Root Ganglion Stimulator For Pain Relief
PMA: P150004
·
Supplement: S035
·
Decision May 6, 2020
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Dorsal Root Ganglion Stimulator For Pain Relief
- Trade Name
- Proclaim DRG IPG
- PMA Number
- P150004
- Supplement Number
- S035
- Device Class
- FDA Class 3
- Product Code
- PMP
- Generic Name
- Dorsal root ganglion stimulator for pain relief
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- May 6, 2020
- Date Received
- April 6, 2020
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Supplier manufacturing site location change for the Flex Assembly component used in the manufacture of Proclaim and Infinity Implantable Pulse Generator devices.
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 |
|---|---|---|---|
| PMP | Dorsal Root Ganglion Stimulator For Pain Relief | FDA class 3 | Unknown |