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 PRIME, PRIMEADVANCED, RESTORE RECHARGEABLE, RESTOREULTRA, RESTOREADVANCED RECHARGEABLE |
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 | S131 |
Date Received | 02/23/2009 |
Decision Date | 04/20/2009 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODEL 74001 (1X4) POCKET ADAPTOR AND MODEL 74002 (2X4) POCKET ADAPTOR. |
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