Tendril STS
FDA premarket approval P960013/S114 · decided 2020-12-16
Approval details
- PMA number
- P960013
- Supplement
- S114
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Tendril STS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-09-29
- Decision date
- 2020-12-16
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for 3T MR Conditional labeling of certain Assurity MRI and Endurity MRI models when combined with a subset (46 cm, 52 cm and 58 cm) of Tendril STS Model 2088TC leads.
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