FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Neuromodulator For Obesity
PMA: P130019
·
Supplement: S015
·
Decision Jan 24, 2018
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Neuromodulator For Obesity
- Trade Name
- Maestro Rechargeable System
- PMA Number
- P130019
- Supplement Number
- S015
- Device Class
- FDA Class 3
- Product Code
- PIM
- Generic Name
- neuromodulator for obesity
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 24, 2018
- Date Received
- June 8, 2017
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
Approval of the revised protocol for the post-approval study (PAS) protocol.
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 |
|---|---|---|---|
| PIM | Neuromodulator For Obesity | FDA class 3 | Unknown |