FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Sharps Needle Destruction Device
PMA: P960018
·
Supplement: S001
·
Decision Nov 17, 1998
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Sharps Needle Destruction Device
- Trade Name
- THE NEEDLE DESTROYER
- PMA Number
- P960018
- Supplement Number
- S001
- Device Class
- FDA Class 2
- Product Code
- MTV
- Generic Name
- Sharps needle destruction device
- Regulation Number
- 880.6210
- Medical Specialty
- General Hospital
- Advisory Committee
- General Hospital
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 17, 1998
- Date Received
- October 14, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a change to the battery charger and the associated instructions for use.
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 |
|---|---|---|---|
| MTV | Sharps Needle Destruction Device | FDA class 2 | General Hospital |