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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.
 
DeviceESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BOSTONSCIENTIFIC
4100 hamline avenue north
st paul, MN 55112
PMA NumberP150012
Supplement NumberS002
Date Received05/02/2016
Decision Date05/31/2016
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Implementation of the following previously accepted manufacturing changes: 1) Removal of a plating process on the crystal oscillator component; 2) modifications to the crystal oscillator manufacturing process; 3) addition of an alternate supplier of a battery raw material; 4) addition of an alternate supplier of the power conductor component; 5) addition of an alternate supplier of the telemetry coils; 6) addition of an alternate supplier of capacitors; 7) addition of an automated visual inspection system for coil springs; 8) addition of an automated packaging line; and 9) vertical integration of the spring connector housing block.
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