|
Device | AT500DDDRP PACING SYSTEM & MODEL 9968 SOFTWARE |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S027 |
Date Received | 03/31/2003 |
Decision Date | 04/16/2003 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MOVE THE MANUFACTURING SITE FROM MEDTRONIC'S EUROPEAN OPERATIONS CENTER (EOC) IN KERKRADE, THE NETHERLANDS TO MEDTRONIC'S EOC, HEERLEN, THE NETHERLANDS. |