- Device
- Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa ProMRI SD 6
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S148
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-07-01
- Decision code
- OK30
- Date received
- 2026-06-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement an alternate manufacturing site for coils used as conductors in BIOTRONIK cardiac rhythm management leads