- Device
- MOMENTUM™ CRT-D IS1 DF4 IS1 (G124, G125); MOMENTUM™ CRT-D IS1 DF1 LV1 (G126); MOMENTUM™ X4 CRT-D IS1 DF1 IS4 (G128, G138
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S613
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2026-07-23
- Decision code
- OK30
- Date received
- 2026-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add a functionally equivalent alternate vapor degreasing solvent used to remove contaminants from pulse generator components