FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
PMA: P970013
·
Supplement: S070
·
Decision Oct 20, 2017
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Pulse-Generator, Single Chamber, Sensor Driven, Implantable
- Trade Name
- Microny SR+ Regency SC+
- PMA Number
- P970013
- Supplement Number
- S070
- 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
- October 20, 2017
- Date Received
- February 7, 2017
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the Merlin Patient Care System (PCS) Model 3330 version 23.0.1 Software for the Merlin PCS Model 3650 Programmer.
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 |