Tendril STS 2088TC Lead
FDA premarket approval P910023/S410 · decided 2018-12-13
Approval details
- PMA number
- P910023
- Supplement
- S410
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Tendril STS 2088TC Lead
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-06-20
- Decision date
- 2018-12-13
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- 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.
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