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 | RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD |
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 | S194 |
Date Received | 07/22/2011 |
Decision Date | 08/17/2011 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES. |
|
|