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. |
|
Device | Activa Deep Brain Stimulation Therapy System |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S374 |
Date Received | 04/09/2020 |
Decision Date | 05/08/2020 |
Product Code |
MHY |
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 Change requested to modify the procedure for the assessment of device bioburden at Medtronic's final device manufacturing facilities-Medtronic Puerto Rico Operations Company, located in Juncos, Puerto Rico .The change also requested other related administrative changes which update the procedure. |
|
|