PMA P030054S355
- Device
- Tendril STS 2088TC Lead
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S355
- Product code
- NIK
- Decision date
- 2018-12-13
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Approval for MR Conditional labeling of the Tendril STS 2088TC lead as part of approved 1.5T MR Conditional pacemaker, ICD and CRT-D systems.
Current openFDA PMA Record#
- Device
- Tendril STS 2088TC Lead
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S355
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-12-13
- Decision code
- APPR
- Date received
- 2018-06-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for MR Conditional labeling of the Tendril STS 2088TC lead as part of approved 1.5T MR Conditional pacemaker, ICD and CRT-D systems.