PMA P830045S050

Device: AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S050
Product code: LWP
Decision date: 1995-11-13
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR THE INCORPORATION OF A "NITROGEN BLANKET" TO THE STERILIZATION PROCESS USED AT THE SYLMAR, CA, FACILITY OF PACESETTER, INC.

Current openFDA PMA Record

Device: AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S050
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1995-11-13
Decision code: APPR
Date received: 1995-10-02
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE INCORPORATION OF A "NITROGEN BLANKET" TO THE STERILIZATION PROCESS USED AT THE SYLMAR, CA, FACILITY OF PACESETTER, INC.