FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Defibrillator, Implantable, Dual-Chamber
PMA: P050023
·
Supplement: S128
·
Decision Apr 15, 2019
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Defibrillator, Implantable, Dual-Chamber
- Trade Name
- Ilesto 7 VR-T, Iforia 7 VR-T, Ilesto 5 VR-T, Iforia 5 VR-T, Inventra 7 VR-T, Iperia 7 VR-T, Itrevia 7 VR-T, Iperia 5 VR-
- PMA Number
- P050023
- Supplement Number
- S128
- 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
- April 15, 2019
- Date Received
- December 11, 2018
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval of the revised protocol for the Protego DF4 Post Approval Registry.
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 |