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Device | MEDTRONIC LEFT VENTRICULAR PACING LEAD, ATTAIN BIPOLAR OTW MODEL 4194 |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S012 |
Date Received | 02/09/2004 |
Decision Date | 08/20/2004 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATION TO THE COIL AND INNER LUMEN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATTAIN BIPOLAR OTW MODEL 4194 AND IS INDICATED FOR USE AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM. |
Post-Approval Study | Show Report Schedule and Study Progress |