|
Device | LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460 |
Generic Name | Pacemaker/icd/crt non-implanted components |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S151 |
Date Received | 12/21/2015 |
Decision Date | 02/05/2016 |
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 patient management system. |