|
Device | LEAD ADAPTERS MODEL NUMBER 6024 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S047 |
Date Received | 08/17/2004 |
Decision Date | 09/13/2004 |
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 IN THE SUPPLIER THAT PROVIDES THE MOLD RELEASE COATING THAT IS USED ON THE SLEEVE OF THE LEAD ADAPTERS TO PREVENT THE BONDING OF THE SILICON SLEEVE TO ITSELF. |