|
Device | ENTOTAK LEAD SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S120 |
Date Received | 08/19/2013 |
Decision Date | 09/17/2013 |
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 | Yes |
Approval Order Statement ADD A NEW PRIMARY SUPPLIER OF THE SERIAL NUMBER LABELS FOR THE DEFIBRILLATION LEADS AND CORONARY SINUS LEADS FOR THE DEVICES. |