PMA P820076S023
- Device
- PERMANENT PACEMAKER ELECTRODE
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S023
- Product code
- LWP
- Decision date
- 2002-12-20
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- REDUCTION IN THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS UTILIZED DURING THE STANDARD STERILIZATION PROCESS, FROM 7 DAYS TO 3 DAYS.
Current openFDA PMA Record#
- Device
- PERMANENT PACEMAKER ELECTRODE
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S023
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2002-12-20
- Decision code
- OK30
- Date received
- 2002-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REDUCTION IN THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS UTILIZED DURING THE STANDARD STERILIZATION PROCESS, FROM 7 DAYS TO 3 DAYS.