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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC SIGMA/MEDTRONIC 350 SERIES PULSE GENERATORS PRODUCTS
Generic Nameimplantable pulse generator programming software
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS011
Date Received07/16/2001
Decision Date08/22/2001
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for alternate manufacturing, packaging and sterilization facilities at medtronic bv, the netherlands and medtronic europe s. A. , tolochenaz, switzerland.
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