|
Device | RELIANCE ENDOTAK IMPLANTABLE LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S086 |
Date Received | 08/10/2010 |
Decision Date | 09/08/2010 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO ACTIVATE THE PERSIST FUNCTION IN THE MANUFACTURING AUTOMATED TRACEABILITY TRACKING (MATT) SYSTEM USED DURING THE MANUFACTURING OF LEADS. |