Torque Wrench/Torque Driver
FDA premarket approval P910023/S416 · decided 2019-05-30
Approval details
- PMA number
- P910023
- Supplement
- S416
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Torque Wrench/Torque Driver
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-03-01
- Decision date
- 2019-05-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for changes to the Torque Wrench/Torque Driver, Model 442-2, accessory.
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