|
Device | ENDOTAK LEAD ADAPTOR MODEL 6952 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S072 |
Date Received | 03/21/2008 |
Decision Date | 07/03/2008 |
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 FOR A MODIFICATION TO THE SPLIT TUBE WELD FOR ENDOTAK LEAD ADAPTOR MODEL 6952. |