|
Device | EMBLEM™ MRI S-CD Pulse Generator (PG) Model A219, EMBLEM™ S-CD Pulse Generator (PG) Model A209 |
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 | S069 |
Date Received | 10/31/2016 |
Decision Date | 11/29/2016 |
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 Addition of a new dispense system in the pulse generator header manufacturing process. |