|
Device | MODEL 7427V SYNERGY VERSITREL DUAL CHANNEL IMPLANTABLE PULSE GENERATOR |
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 | S058 |
Date Received | 10/22/2001 |
Decision Date | 12/14/2001 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MODEL 7427V SYNERGY VERSITREL DUAL CHANNEL IMPLANTABLE PULSE GENERATOR AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTACTABLE PAIN OF THE TRUNK OR LIMBS. |