FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Defibrillator, Implantable, Dual-Chamber
PMA: P050023
·
Supplement: S036
·
Decision Aug 20, 2010
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Defibrillator, Implantable, Dual-Chamber
- Trade Name
- LUMAX FAMILIES OF ICDS & CRT-DS
- PMA Number
- P050023
- Supplement Number
- S036
- Device Class
- FDA Class 3
- Product Code
- MRM
- Generic Name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 20, 2010
- Date Received
- July 21, 2010
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
NEW SUPPLIER OF A COMMUNICATION COMPONENT.
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 |