PMA P830060S049

Device: MODEL 6577 STERILIZABLE TELEMETRY WAND
Applicant: Boston Scientific
PMA number: P830060
Supplement: S049
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: MODEL 6577 STERILIZABLE TELEMETRY WAND
Applicant: Boston Scientific
PMA number: P830060
Supplement: S049
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.