FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Generator, Shock-Wave, For Pain Relief
PMA: P050004
·
Supplement: S001
·
Decision Aug 28, 2009
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Generator, Shock-Wave, For Pain Relief
- Trade Name
- EMS-SWISS DOLORCLAST
- PMA Number
- P050004
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- NBN
- Generic Name
- Generator, shock-wave, for pain relief
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 28, 2009
- Date Received
- February 25, 2009
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT E.M.S. ELECTRO MEDICAL SYSTEMS, SA, NYON, SWITZERLAND.
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 |
|---|---|---|---|
| NBN | Generator, Shock-Wave, For Pain Relief | FDA class 3 | Unknown |