FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implantable Pulse Generator, Pacemaker (Non-Crt)
PMA: P820018
·
Supplement: S073
·
Decision Sep 24, 1999
Classifications
1
FEI Numbers
35
Registration Numbers
35
Basic Information
- Device Name
- Implantable Pulse Generator, Pacemaker (Non-Crt)
- Trade Name
- NETWORK PROGRAMMER
- PMA Number
- P820018
- Supplement Number
- S073
- Device Class
- FDA Class 3
- Product Code
- LWP
- Generic Name
- Implantable pulse generator, pacemaker (non-CRT)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 24, 1999
- Date Received
- September 7, 1999
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the Version R5.111WE programmer software for the Model 9602 Programmer.
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 |
|---|---|---|---|
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA class 3 | Unknown |