PMA P950037S109
- Device
- RELIATY / MODEL 3145 PACING SYSTEM
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S109
- Product code
- OVJ
- Decision date
- 2012-08-28
- Classification
- Pulse Generator, External Pacemaker, Dual Chamber
- Generic name
- Pulse Generator, External Pacemaker, Dual Chamber
- Approval order statement
- APPROVAL FOR FIRMWARE MODIFICATIONS AND LABELING UPDATES TO THE DEVICES.
Current openFDA PMA Record#
- Device
- RELIATY / MODEL 3145 PACING SYSTEM
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S109
- Product code
- OVJ
- Generic name
- Pulse Generator, External Pacemaker, Dual Chamber
- Decision date
- 2012-08-28
- Decision code
- APPR
- Date received
- 2012-06-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR FIRMWARE MODIFICATIONS AND LABELING UPDATES TO THE DEVICES.