|
Device | ACTIVA TREMOR CONTROL SYSTEM |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S022 |
Date Received | 11/13/2001 |
Decision Date | 12/11/2001 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
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 TO THE MANUFACTURING PROCESS TO INCLUDE AN ADDITIONAL METHOD FOR MONITORING ETHYLENE GAS CONCENTRATIONS DURING THE STERILIZATION PROCESS. |
Post-Approval Study | Show Report Schedule and Study Progress |