PMA P940008S002

Device: RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
Applicant: Boston Scientific
PMA number: P940008
Supplement: S002
Product code: LWS
Decision date: 1996-08-20
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: APPROVAL FOR A SUPPLEMENT WHICH SATISFIES THE REQUIREMENT TO SUBMIT A POST-APPROVAL STUDY PROTOCOL FOR THE INTERMEDICS EPICARDIAL PATCH DEFIBRILLATION LEADS. THE POST APPROVAL STUDY WAS REQUIRED AS A CONIDTIN OF APPROVAL IN OUR LETTER DATED NOVEMBER 7, 1995

Current openFDA PMA Record

Device: RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
Applicant: Boston Scientific
PMA number: P940008
Supplement: S002
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 1996-08-20
Decision code: APPR
Date received: 1996-02-05
Supplement type: Normal 180 Day Track
Supplement reason: Other
Approval order statement: APPROVAL FOR A SUPPLEMENT WHICH SATISFIES THE REQUIREMENT TO SUBMIT A POST-APPROVAL STUDY PROTOCOL FOR THE INTERMEDICS EPICARDIAL PATCH DEFIBRILLATION LEADS. THE POST APPROVAL STUDY WAS REQUIRED AS A CONIDTIN OF APPROVAL IN OUR LETTER DATED NOVEMBER 7, 1995