- Device
- Origen Mini ICD VR, Origen Mini ICD DR, Inogen Mini ICD VR, Inogen Mini ICD DR, Dynagen Mini ICD VR, Dynagen Mini ICD DR
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S445
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-12-04
- Decision code
- OK30
- Date received
- 2019-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a post-reflow manufacturing inspection for printed circuit boards.