PMA P880006S023
- Device
- Afp Cardiac Pacing System, Sensolog Cardiac Pacing
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S023
- Decision date
- 1995-11-13
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
- P880006
- Supplement
- S023
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- 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.