- Device
- ORIGEN™ CRT-D, ORIGEN™ X4 CRT-D, MOMENTUM™ CRT-D, MOMENTUM, MOMENTUM™ X4 CRT-D, INOGEN™ CRT-D, INOGEN™ X4 CRT-D, DYNAGEN
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S549
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-12-21
- Decision code
- OK30
- Date received
- 2021-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add alternate nitrile gloves to be used in the manufacturing operations at BSC-Clonmel.