PMA P960013S098
- Device
- Tendril STS 2088TC Lead
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S098
- Product code
- NVN
- Decision date
- 2018-12-13
- Classification
- Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- 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
- P960013
- Supplement
- S098
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- 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.