PMA P940008S030

Device: RES-Q FAMILY OF ICD/ICD LEADS, RES-Q MICRON FAMILY OF ICDS
Applicant: Boston Scientific
PMA number: P940008
Supplement: S030
Product code: LWS
Decision date: 2012-11-09
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.

Current openFDA PMA Record

Device: RES-Q FAMILY OF ICD/ICD LEADS, RES-Q MICRON FAMILY OF ICDS
Applicant: Boston Scientific
PMA number: P940008
Supplement: S030
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2012-11-09
Decision code: OK30
Date received: 2012-10-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.