- Device
- ORIGEN VR, ORIGEN DR, INOGEN DR, INOGEN VR, DYNAGEN VR, DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S470
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-09-24
- Decision code
- OK30
- Date received
- 2021-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the adhesive and liner used on the tray label stock for pulse generators and Leads.