PMA P830060S047

Device: VENTAK(R) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Applicant: Boston Scientific
PMA number: P830060
Supplement: S047
Product code: LWS
Decision date: 2000-02-23
Classification: Implantable Cardioverter Defibrillator (non-crt)
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: All previously marketed Intermedics stylets to be marketed under new Guidant model numbers, and an alternate stylet kit package insert.

Current openFDA PMA Record#

Device: VENTAK(R) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Applicant: Boston Scientific
PMA number: P830060
Supplement: S047
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2000-02-23
Decision code: APPR
Date received: 2000-01-11
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: All previously marketed Intermedics stylets to be marketed under new Guidant model numbers, and an alternate stylet kit package insert.