PMA P950037S121
- Device
- PHILOS DR-T,PHILOS II DR-T,CYLOS DR-T,EVIA DR-T/EVIA SR-T,ENTOVIS DR-T/ENTOVIS SR-T,ESTELLA DR-T/ESTELLA SR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S121
- Product code
- NVZ
- Decision date
- 2013-05-08
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR THE UPDATED VERSION 3.22.0 OF HOME MONITORINGSERVICE CENTER INCLUDING THE FEATURES:1) IMPLEMENTATION OF REMOTE SCHEDULING; AND2) AUTOMATIC EXPORT OF EHR DATA.
Current openFDA PMA Record#
- Device
- PHILOS DR-T,PHILOS II DR-T,CYLOS DR-T,EVIA DR-T/EVIA SR-T,ENTOVIS DR-T/ENTOVIS SR-T,ESTELLA DR-T/ESTELLA SR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S121
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2013-05-08
- Decision code
- APPR
- Date received
- 2013-04-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE UPDATED VERSION 3.22.0 OF HOME MONITORINGSERVICE CENTER INCLUDING THE FEATURES:1) IMPLEMENTATION OF REMOTE SCHEDULING; AND2) AUTOMATIC EXPORT OF EHR DATA.