|
Device | LATITUDE NXT PATIENT MANAGEMENT SYSTEM |
Generic Name | Pacemaker/icd/crt non-implanted components |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S149 |
Date Received | 04/27/2015 |
Decision Date | 07/21/2015 |
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 UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0). |