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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.
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
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.