PMA P820076S026
- Device
- DIPLOS MODEL 05 A & B
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S026
- Product code
- LWP
- Decision date
- 2018-02-21
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Use of supplemental sterilization equipment and a new sterilization process for implantable leads and accessories.
Current openFDA PMA Record#
- Device
- DIPLOS MODEL 05 A & B
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S026
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-02-21
- Decision code
- OK30
- Date received
- 2018-01-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of supplemental sterilization equipment and a new sterilization process for implantable leads and accessories.