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Device | Model 3501 EMBLEM S-ICD subcutaneous Electrode |
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 | S077 |
Date Received | 02/06/2017 |
Decision Date | 09/29/2017 |
Product Codes |
LWS NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 180 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the EMBLEM S-ICD Electrode Model 3501 and labeling changes to the components of the EMBLEM S-ICD System. |
Post-Approval Study | Show Report Schedule and Study Progress |