- 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
- S449
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-03-17
- Decision code
- OK30
- Date received
- 2020-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement the CMS system for the monitoring of environmental conditions at the Boston Scientific Clonmel facility.