|
Device | Micra Transcatheter Pacing System |
Generic Name | Leadless pacemaker |
Regulation Number | 870.3610 |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P150033 |
Supplement Number | S026 |
Date Received | 07/28/2017 |
Decision Date | 08/18/2017 |
Product Code |
PNJ |
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 Changes to the curve bake and silicone application worksteps of the Micra delivery system manufacturing process. |