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 | ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S227 |
Date Received | 05/11/2015 |
Decision Date | 06/08/2015 |
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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