FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Neuromodulator For Obesity
PMA: P130019
·
Supplement: S007
·
Decision Feb 12, 2016
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
- S007
- Device Class
- FDA Class 3
- Product Code
- PIM
- Generic Name
- neuromodulator for obesity
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 12, 2016
- Date Received
- January 20, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Material change for the flux used during in-process rework, the use of a 10 zone Vitronics reflow oven, machine placement of the RF shield component, clarifying process instructions, and use of the alternate Mydata assembly line for the Model 2402 Mobile Charger.
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 |