PMA P950037S088
- Device
- RELIATY / MODEL 3145 FAMILY OF PACING SYSTEM ANALYZERS
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S088
- Product code
- OVJ
- Decision date
- 2011-04-20
- Classification
- Pulse Generator, External Pacemaker, Dual Chamber
- Generic name
- Pulse Generator, External Pacemaker, Dual Chamber
- Approval order statement
- APPROVAL FOR: 1) NEW DISPLAY SCREEN; 2) ALTERNATE BATTERY; 3) MODIFIED BATTERY CARTRIDGE; 4) MODIFIED BATTERY CONTACTS; 5) NEW FIRMWARE; 6) UPDATED SOFTWARE; 7) MODIFIED CONTROL KNOB; 8) MODIFIED CIRCUIT BOARDS; AND 9) TECHNICAL MANUAL AND DEVICE LABELING CHANGES.
Current openFDA PMA Record#
- Device
- RELIATY / MODEL 3145 FAMILY OF PACING SYSTEM ANALYZERS
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S088
- Product code
- OVJ
- Generic name
- Pulse Generator, External Pacemaker, Dual Chamber
- Decision date
- 2011-04-20
- Decision code
- APPR
- Date received
- 2010-10-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR: 1) NEW DISPLAY SCREEN; 2) ALTERNATE BATTERY; 3) MODIFIED BATTERY CARTRIDGE; 4) MODIFIED BATTERY CONTACTS; 5) NEW FIRMWARE; 6) UPDATED SOFTWARE; 7) MODIFIED CONTROL KNOB; 8) MODIFIED CIRCUIT BOARDS; AND 9) TECHNICAL MANUAL AND DEVICE LABELING CHANGES.