|
Device | SYNERGYST PULSE II GENERATOR |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S072 |
Date Received | 08/22/2003 |
Decision Date | 11/17/2003 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO. |