|
Device | Emblem S-ICD Programmer - Plexus SMT Mfg. Line |
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 | S079 |
Date Received | 02/22/2017 |
Decision Date | 03/21/2017 |
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 New manufacturing line for the programmer radio board printed circuit board assembly for the Model 3200 EMBLEM Programmer. |