Bi-Directional Torque Wrench Model 6628
FDA premarket approval P010012/S558 · decided 2022-11-15
Approval details
- PMA number
- P010012
- Supplement
- S558
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Bi-Directional Torque Wrench Model 6628
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Boston Scientific Corp
- Date received
- 2022-09-22
- Decision date
- 2022-11-15
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for changes to the package label and the instructions for use of the Bi-Directional Torque Wrench Model 6628.
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