PMA P110042S017

Device: SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S017
Product code: LWS
Decision date: 2014-04-02
Classification: Implantable Cardioverter Defibrillator (non-crt)
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT CAMERON HEALTH, INC., A SUBSIDIARY OF BOSTON SCIENTIFIC CORPORATION, IN TIPPERARY, IRELAND.

Current openFDA PMA Record#

Device: SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S017
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2014-04-02
Decision code: APPR
Date received: 2013-09-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT CAMERON HEALTH, INC., A SUBSIDIARY OF BOSTON SCIENTIFIC CORPORATION, IN TIPPERARY, IRELAND.