|
Device | ENDOTAK RELIANCE G/SG LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S061 |
Date Received | 12/02/2005 |
Decision Date | 12/30/2005 |
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 MANUFACTURING PROCESS THAT IMPROVES THE DISTAL COIL BONDING PROCESS BY 1) CHANGING THE CONSTITUTION OF THE BONDING ADHESIVE, 2) CHANGING THE TOOL USED TO APPLY THE BONDING ADHESIVE, AND 3) ADDING DIAGRAMS TO THE MANUFACTURING INSTRUCTIONS FOR THE LEADS. |