|
Device | TRANSVENE LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980050 |
Supplement Number | S072 |
Date Received | 03/26/2012 |
Decision Date | 07/18/2012 |
Product Code |
LWS |
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 TO CHANGE IN SILICONE TUBING MATERIAL USED IN THE MANUFACTURING OF VARIOUS CARDIAC LEADS AS A RESULT OF DISCONTINUATION OF THE CURRENT MATERIAL BY AN OUTSIDE SUPPLIER. |