|
Device | EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT 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 | S448 |
Date Received | 11/19/2013 |
Decision Date | 12/17/2013 |
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 MANUFACTURE UPDATE TO THE 0.8 ÌM BICMOS (BIPOLAR COMPLEMENTARY METAL OXIDE SEMICONDUCTOR) PROCESS FLOW AT THE IC SUPPLIER. |