|
Device | RELIANCE IS-1 FAMILY OF LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S089 |
Date Received | 10/29/2010 |
Decision Date | 06/14/2011 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ACCEPTANCE OF AN ENHANCEMENT TO THE INSULATION AND TRI-LUMEN BOND PROCESS, TO INCLUDE AN UPGRADE OF THE BONDING EQUIPMENT AND ADDITIONAL ACCEPTANCE ACTIVITY INSPECTIONS TO VERIFY AN ADEQUATE BOND WHICH WILL PREVENT FLUID LEAKAGE. |