PMA P960013S016
- Device
- TENDRIL MODEL 1488T/TC AND 1688T/TC LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S016
- Product code
- DTB
- Decision date
- 2006-03-02
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- ADDITION OF AN INSPECTION FOR MEDICAL ADHESIVE ON THE HELIX DURING PRODUCTION.
Current openFDA PMA Record#
- Device
- TENDRIL MODEL 1488T/TC AND 1688T/TC LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S016
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2006-03-02
- Decision code
- OK30
- Date received
- 2006-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN INSPECTION FOR MEDICAL ADHESIVE ON THE HELIX DURING PRODUCTION.