|
Device | ITREL 3, SOLETRA, DCI (SYNERGY) |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S033 |
Date Received | 10/06/2005 |
Decision Date | 02/16/2006 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANALYSIS. |
Post-Approval Study | Show Report Schedule and Study Progress |