- Device
- Tachy Pulse Generators
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S612
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2026-08-25
- Decision code
- APPR
- Date received
- 2026-06-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the SMR16 software maintenance release to update the NG4 pulse generator firmware and Model 3868 Tachy programmer software application