|
Device | CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S- ICD SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC CORPORATION 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P110042 |
Supplement Number | S021 |
Date Received | 11/06/2013 |
Decision Date | 12/03/2013 |
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 | No |
Approval Order Statement ADD A SECOND SUPPLIER FACILITY FOR PERFORMING LASER WELDING AND WETBLAST PROCESSES. |