|
Device | UNIPOLAR/ LEAD END PIN CAP/OVAL PATCH LEAD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P900061 |
Supplement Number | S111 |
Date Received | 11/21/2011 |
Decision Date | 02/28/2013 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE ACCESSORY UPSIZING SLEEVES, LEAD END PIN CAP, AND OVAL PATCH LEAD. |