|
Device | SPINAL CORD STIMULATION (SCS) INPLANTABLE NEUROSTIMULATORS (INS) RESTORE FAMILY |
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 | S212 |
Date Received | 04/10/2012 |
Decision Date | 05/10/2012 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement CHANGES IN THE MANUFACTURING PROCESS AT MEDTRONIC¿S SUPPLIER OF GROMMETS USED IN VARIOUS MEDTRONIC NEUROMODULATION IMPLANTABLE DEVICES. |