PMA P820076S028
- Device
- EFH-16; S60-K; S 60-J; S 60-S
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S028
- Product code
- LWP
- Decision date
- 2018-08-09
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Changes to the sterilization process used for leads and accessories.
Current openFDA PMA Record#
- Device
- EFH-16; S60-K; S 60-J; S 60-S
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S028
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-08-09
- Decision code
- OK30
- Date received
- 2018-07-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the sterilization process used for leads and accessories.