- Device
- INOGEN™ MINI ICD VR, INOGEN™ MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN™ MINI ICD DR, MOMENTUM™ EL ICD VR, MOMENTUM™ EL
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S488
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-12-14
- Decision code
- OK30
- Date received
- 2022-12-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new cleanroom to the BSC-Clonmel manufacturing facility.