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 | POCKET ADAPTOR KIT, ITREL 3, SYNERGY & SYNERGY VERSITREL |
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 | S205 |
Date Received | 03/16/2012 |
Decision Date | 04/12/2012 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADD TWO ALTERNATE SUPPLIERS FOR THE OUTER SEAL COMPONENT. |
|
|