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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.
 
DeviceNextGen DRG Lead Kit and Accessories
Generic NameDorsal root ganglion stimulator for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP150004
Supplement NumberS044
Date Received12/28/2020
Decision Date06/22/2021
Product Code PMP 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for design changes to the delivery sheath and tunneling tool, including a new material and locking mechanism for the delivery sheath and a new handle and tip design for the tunneling tool, changes to the packaging configurations of the lead kit and accessories kit, and minor labeling changes to reflect the design and packaging changes. This supplement also requested approval for the addition of Microlumen, Inc. as the new supplier of the delivery sheath, Spectra Medical Inc. as the new supplier of the tunneling tool, and Xylem Company as an alternate supplier for the straight stylet.
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