Leadless Pacemaker
Basic Information
- Device Name
- Leadless Pacemaker
- Trade Name
- MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
- PMA Number
- P150033
- Device Class
- FDA Class 3
- Product Code
- PNJ
- Generic Name
- Leadless pacemaker
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 6, 2016
- Date Received
- September 17, 2015
- Expedited Review
- Y
- Docket Number
- 16M-1125
Advisory Committee Statement
Approval for the Micra Transcatheter Pacemaker System (Pacemaker Model MC1VR01 and Programmer Application Software model SW022 Version 1.1). This device is indicated for use in patients who have experienced one or more of the following conditions: symptomatic paroxysmal or permanent high-grade AV block in the presence of AF symptomatic paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapyRate-responsive pacing is indicated to provide increased heart rate appropriate to increasing levels of activity.
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 |
|---|---|---|---|
| PNJ | Leadless Pacemaker | FDA class 3 | Cardiovascular |