Implantable Pulse Generator, Pacemaker (Non-Crt)
Basic Information
- Device Name
- Implantable Pulse Generator, Pacemaker (Non-Crt)
- Trade Name
- REVO MRI SURESCAN IPG AND PACING SYSTEM
- PMA Number
- P090013
- Device Class
- FDA Class 3
- Product Code
- LWP
- Generic Name
- Implantable pulse generator, pacemaker (non-CRT)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 8, 2011
- Date Received
- June 9, 2009
- Expedited Review
- N
- Docket Number
- 11M-0105
Advisory Committee Statement
APPROVAL FOR THE REVO MRISURESCAN PACING SYSTEM, WHICH CONSISTS OF THE MEDTRONIC REVO MRI¿ SURESCAN¿ MODEL RVDR01 IPG, THE MEDTRONIC CAPSUREFIX MRI¿ SURESCAN¿ 5086MRI LEAD, AND THE REVO MRI¿ SOFTWARE APPLICATION MODEL SW018. THIS SYSTEM IS INDICATED AS FOLLOWS:THE MEDTRONIC REVO MRI¿ SURESCAN¿ MODEL RVDR01 IPG IS INDICATED FOR USE AS A SYSTEM CONSISTING OF A REVO MRI SURESCAN IPG IMPLANTED WITH TWO CAPSURE FIX MRI¿SURESCAN¿ 5086MRI LEADS. A COMPLETE SYSTEM IS REQUIRED FOR USE IN THE MRI ENVIRONMENT.THE MEDTRONIC REVO MRI¿ SURESCAN¿ MODEL RVDR01 IPG IS INDICATED FOR THEFOLLOWING:1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RALESCONCURRENT WITH INCREASES IN ACTIVITY;2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING INCLUDE:A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND-DEGREE OR THIRD-DEGREE AV BLOCK;B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK;C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; ANDD) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOMEFORMS OF SYMPTOMATIC TACHYARRHYTHMIAS...(SEE APPROVAL ORDER FOR ADD'L DETAIL)
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 |
|---|---|---|---|
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA class 3 | Unknown |