FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
PMA: P970013
·
Supplement: S076
·
Decision Apr 11, 2018
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Pulse-Generator, Single Chamber, Sensor Driven, Implantable
- Trade Name
- Microny family of Pacemakers
- PMA Number
- P970013
- Supplement Number
- S076
- Device Class
- FDA Class 3
- Product Code
- LWO
- Generic Name
- Pulse-generator, single chamber, sensor driven, implantable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 11, 2018
- Date Received
- January 18, 2018
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for cybersecurity updates and implementation of a Battery Performance Alert in the firmware of ICDs and CRT-Ds.
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 |
|---|---|---|---|
| LWO | Pulse-Generator, Single Chamber, Sensor Driven, Implantable | FDA class 3 | Unknown |