|
Device | Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD/Visia AF MRI VR ICD/Visia AF VR ICD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S644 |
Date Received | 09/20/2017 |
Decision Date | 10/20/2017 |
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 | Yes |
Approval Order Statement Addition of manufacturing equipment for use in the connector second shot molding process. |