|
Device | VITATRON DA+C & VITATRON DA+T SERIES IPGS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P990001 |
Supplement Number | S092 |
Date Received | 07/06/2011 |
Decision Date | 08/04/2011 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION. |