|
Device | INSYNC REGISTRY |
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 | S013 |
Date Received | 05/19/2004 |
Decision Date | 08/12/2005 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO INCORPORATE CRT DEVICES WITH DEFIBRILLATOR CAPABILITIES (CRT-D INTO THE INSYNC REGISTRY. |
Post-Approval Study | Show Report Schedule and Study Progress |