|
Device | MEDTRONIC ATTAIN OTW LV LEAD MODEL 4193 |
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 | S030 |
Date Received | 06/27/2007 |
Decision Date | 02/14/2008 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD AN UPDATED VERSION OF THE POST-APPROVAL STUDY SUMMARY FOR THE ATTAIN OTW LV LEAD MODEL 4193 TO THE DEVICE LABELING. |