- Device
- Bi-Directional Torque Wrench Model 6628
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S558
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2022-11-15
- Decision code
- APPR
- Date received
- 2022-09-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the package label and the instructions for use of the Bi-Directional Torque Wrench Model 6628.