|
Device | CareLink Programmer (Model 2090), Encore Programmer (Model 29901) |
Generic Name | Pacemaker/icd/crt non-implanted components |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S350 |
Date Received | 03/17/2016 |
Decision Date | 04/28/2016 |
Product Code |
OSR |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for software changes to the Reveal LINQ FullView Application Software. |