PMA P820076S020
- Device
- BIOTRONIK GEMNOS 04, 04A, AND TC 04
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S020
- Product code
- LWP
- Decision date
- 1995-12-22
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE CHANGE IN THE BURN-IN PROCESSING OF THE WILSON GREATBATCH BATTERIES WHICH ARE USED IN YOUR LISTED PACEMAKERS. THIS PROCESS CHANGE IS A REDUCTION OF THE BATTERY BURN-IN TIME FROM 35 DAYS TO 4 DAYS
Current openFDA PMA Record#
- Device
- BIOTRONIK GEMNOS 04, 04A, AND TC 04
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S020
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1995-12-22
- Decision code
- APPR
- Date received
- 1995-05-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE CHANGE IN THE BURN-IN PROCESSING OF THE WILSON GREATBATCH BATTERIES WHICH ARE USED IN YOUR LISTED PACEMAKERS. THIS PROCESS CHANGE IS A REDUCTION OF THE BATTERY BURN-IN TIME FROM 35 DAYS TO 4 DAYS