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. |
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Device | Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Extensions, Specify, and Vectris Spinal |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432 |
PMA Number | P840001 |
Supplement Number | S347 |
Date Received | 11/21/2016 |
Decision Date | 12/15/2016 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Transfer of existing passivation process and corrosion testing to RMS Medical and addition of hydrofluoric acid cleaning step prior to passivation of leads, extensions, and accessories. |
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