PMA P960013S012
- Device
- TENDRIL DX, MODELS 1388 T/K & TENDRIL SDX MODELS 1488 T/K
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S012
- Product code
- DTB
- Decision date
- 2003-01-22
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING BRADYCARDIA LEADS.
Current openFDA PMA Record#
- Device
- TENDRIL DX, MODELS 1388 T/K & TENDRIL SDX MODELS 1488 T/K
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S012
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2003-01-22
- Decision code
- APPR
- Date received
- 2002-12-04
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING BRADYCARDIA LEADS.