FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Programmer, Pacemaker
PMA: P830045
·
Supplement: S075
·
Decision Mar 2, 2001
Classifications
1
FEI Numbers
22
Registration Numbers
22
Basic Information
- Device Name
- Programmer, Pacemaker
- Trade Name
- VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE
- PMA Number
- P830045
- Supplement Number
- S075
- Device Class
- FDA Class 3
- Product Code
- KRG
- Generic Name
- Programmer, pacemaker
- Regulation Number
- 870.3700
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 2, 2001
- Date Received
- February 9, 2001
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE PROGRAMMER SOFTWARE MODEL 3307 V2.1.
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 |
|---|---|---|---|
| KRG | Programmer, Pacemaker | FDA class 3 | Cardiovascular |