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, SPECIFY, AND VECTRIS SPINAL CORD STIMULATIONS LEA |
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 | S301 |
Date Received | 05/11/2015 |
Decision Date | 06/08/2015 |
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 INCOMING INSPECTION ACTIVITIES, FOR A NUMBER OF DEVICE COMPONENTS USED IN THE MANUFACTURE OF NEUROMODULATION LEADS, EXTENSIONS AND ACCESSORIES FROM THE MEDTRONIC RICE CREEK MANUFACTURING FACILITY TO MEDTRONIC PUERTO RICO OPERATION CNETERS (MPROC) IN VILLALBA AND JUNCOS.RANSFER OF INCOMING INSPECTION ACTIVITIES. |
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