|
Device | MEDTRONIC TRANSVENE LEAD SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P920015 |
Supplement Number | S008 |
Date Received | 08/10/1995 |
Decision Date | 12/07/1995 |
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 USE OF AN ALTERNATE STERILIZATION PROCESS AND A MODIFICATION TO THE DISTAL END OF THE TRANSVENE LEADS |