FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Dorsal Root Ganglion Stimulator For Pain Relief
PMA: P150004
·
Supplement: S013
·
Decision Aug 24, 2017
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Dorsal Root Ganglion Stimulator For Pain Relief
- Trade Name
- Cassette and Cassette Spacer
- PMA Number
- P150004
- Supplement Number
- S013
- 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
- August 24, 2017
- Date Received
- August 22, 2017
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
New equipment at an alternate supplier manufacturing location for the cassette and cassette spacer components of the dorsal root ganglion (DRG) implantable pulse generators (IPGs).
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 |