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Device | MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATOR AND MODEL SW003 APPLICATION SOFTWARE |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S073 |
Date Received | 05/10/2007 |
Decision Date | 05/13/2008 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MEDTRONIC ADAPTA/VERSA/SENSIA IMPLANTABLE PACEMAKERS (A/V/S PACEMAKERS), MODEL SW003 APPLICATION SOFTWARE, AND MODEL 2490H MEDTRONIC CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE. |
Post-Approval Study | Show Report Schedule and Study Progress |