PMA P830060S052

Device: BI-DIRECTIONAL TORQUE WRENCH(MODEL 6942)
Applicant: Boston Scientific
PMA number: P830060
Supplement: S052
Product code: LWS
Decision date: 2003-11-21
Classification: Implantable Cardioverter Defibrillator (non-crt)
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order 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.

Current openFDA PMA Record#

Device: BI-DIRECTIONAL TORQUE WRENCH(MODEL 6942)
Applicant: Boston Scientific
PMA number: P830060
Supplement: S052
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2003-11-21
Decision code: APPR
Date received: 2003-10-30
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.