PMA P910077S033

Device: ENDOTAK SQUARE ARRAY XP SUBCUTANEOUS LEAD, SQUARE PATCH LEAD, EPICARDIAL PATCHES
Applicant: Boston Scientific
PMA number: P910077
Supplement: S033
Product code: LWS
Decision date: 2000-09-25
Classification: Implantable Cardioverter Defibrillator (non-crt)
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.

Current openFDA PMA Record#

Device: ENDOTAK SQUARE ARRAY XP SUBCUTANEOUS LEAD, SQUARE PATCH LEAD, EPICARDIAL PATCHES
Applicant: Boston Scientific
PMA number: P910077
Supplement: S033
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2000-09-25
Decision code: APPR
Date received: 2000-08-21
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.