BI-DIRECTIONAL TORQUE WRENCH(MODEL 6942)
FDA premarket approval P830060/S052 · decided 2003-11-21
Approval details
- PMA number
- P830060
- Supplement
- S052
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BI-DIRECTIONAL TORQUE WRENCH(MODEL 6942)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2003-10-30
- Decision date
- 2003-11-21
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A LABELING CHANGE TO INCLUDE TEXT VERSIONS AND MORE DESCRIPTIVE APPLICATION DIAGRAMS FOR USING THE BI-DIRECTIONAL TORQUE WRENCH (MODEL 6942) AND HEX WRENCH (MODEL 6501). THE NEW LABELING ALSO SPECIFIED THAT THE DEVICE IS STERILIZED, NON-PYROGENIC AND SINGLE USE ONLY.
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