|
Device | MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL |
Generic Name | Stimulator, electrical, implantable, for incontinence |
Regulation Number | 876.5270 |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE, N.E. MINNEAPOLIS, MN 55432 |
PMA Number | P970004 |
Supplement Number | S018 |
Date Received | 11/05/2001 |
Decision Date | 12/05/2001 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
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 ADDING AN ADDITIONAL METHOD FOR MONITORING ETHYLENE OXIDE GAS CONCENTRATIONS DURING THE STERILIZATION PROCESS. |