|
Device | EMBLEM™ S-ICD, EMBLEM™ MRI S-ICD |
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 | S188 |
Date Received | 07/18/2023 |
Decision Date | 07/21/2023 |
Product Codes |
LWS NVY |
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 Streamline the bacterial endotoxin testing (BET) method for all items submitted to the Arden Hills Microbiology Lab to one test method. |