- Device
- Pamira S 60; Pamira S 65; Pamira S 75; Pamira SD 60/16; Pamira SD 65/16; Pamira SD 65/18; Pamira SD 75/18; Pamira S DX 6
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S150
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-09-10
- Decision code
- OK30
- Date received
- 2026-08-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to introduce an alternate laser welder for a spot welding process on ICD leads.