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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
Device(Pacemaker Devices) INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BOSTONSCIENTIFIC
4100 hamline avenue north
st paul, MN 55112
PMA NumberP150012
Supplement NumberS092
Date Received03/20/2020
Decision Date06/15/2020
Product Codes NVN  LWP 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for Model 3892 Altrua/Insignia/Nexus I Software Support Application v 1.04, Model 3909 Multiple Application Utility v 1.09, Model 3920 Platform Operating System v1.08, Model 3923 Quick Start Application v1.05 software applications of the Model 3300 LATTITUDE Programming System.
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