- Device
- (Pacemaker Devices) ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S251
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-06-15
- Decision code
- APPR
- Date received
- 2020-03-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for Model 3892 Altrua/Insignia/Nexus I Software Support Application v 1.04, Model 3909 Multiple Application Utility v 1.09, Model 3920 Platform Operating System v1.08, Model 3923 Quick Start Application v1.05 software applications of the Model 3300 LATTITUDE Programming System.