PMA P800041
- Device
- CARBON TIP CARDIAC PACING LEAD
- Applicant
- Pacesetter Systems
- PMA number
- P800041
- Supplement
- S015
- Product code
- DTB
- Decision date
- 1996-01-04
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- APPROVAL FOR THE ADDITION OF A "NITROGEN BLANKET" TO STERILIZATION PROCESS
Current openFDA PMA Record#
- Device
- CARBON TIP CARDIAC PACING LEAD
- Applicant
- Pacesetter Systems
- PMA number
- P800041
- Supplement
- S015
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 1996-01-04
- 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 ADDITION OF A "NITROGEN BLANKET" TO STERILIZATION PROCESS