|
Device | ATTAIN OTW |
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 | S067 |
Date Received | 03/17/2009 |
Decision Date | 04/28/2009 |
Product Code |
LWP |
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 A NEW KIT CONTAINING INDIVIDUALLY PACKAGED LEAD ANCHORING SLEEVES. THE KIT WILL BE MARKETED UNDER THE TRADE NAME MODEL 5867 AS ANCHORING SLEEVE KIT AND IS INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE ENDOCARDIAL LEAD FAMILIES LISTED. |