FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Defibrillator, Implantable, Dual-Chamber
PMA: P000009
·
Supplement: S080
·
Decision Sep 4, 2019
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Defibrillator, Implantable, Dual-Chamber
- Trade Name
- Ilivia Neo 7 DR-T and Intica Neo 7 and 5 DR-T
- PMA Number
- P000009
- Supplement Number
- S080
- Device Class
- FDA Class 3
- Product Code
- MRM
- Generic Name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 4, 2019
- Date Received
- July 1, 2019
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the Ilivia Neo family of ICD and CRT-D devices.
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 |
|---|---|---|---|
| MRM | Defibrillator, Implantable, Dual-Chamber | FDA class 3 | Unknown |