FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Programmer, Pacemaker
PMA: P830045
·
Supplement: S074
·
Decision Dec 12, 2000
Classifications
1
FEI Numbers
22
Registration Numbers
22
Basic Information
- Device Name
- Programmer, Pacemaker
- Trade Name
- INTEGRITY DR MODEL 5336/INTEGRITY SR MODEL 5136
- PMA Number
- P830045
- Supplement Number
- S074
- 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
- December 12, 2000
- Date Received
- November 16, 2000
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR PULSE GENERATOR MODELS INTEGRITY U DR MODEL 5336 AND SR MODEL 5136 PULSE GENERATORS.
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 |