|
Device | EMBLEM S-ICD PULSE GENERATOR |
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 | S053 |
Date Received | 10/14/2015 |
Decision Date | 11/04/2015 |
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 TO ADD AN ADDITIONAL SUPPLIER FOR NICKEL FOIL USED IN THE BATTERY ASSEMBLY. |