FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Neuromodulator For Obesity
PMA: P130019
·
Supplement: S004
·
Decision Apr 22, 2015
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
- S004
- 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
- April 22, 2015
- Date Received
- March 23, 2015
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ACCEPTANCE OF A CHANGE TO THE RELEASE PROCEDURE.
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 |