Tendril MRI Leads
FDA premarket approval P140033/S014 · decided 2017-12-12
Approval details
- PMA number
- P140033
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tendril MRI Leads
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-09-18
- Decision date
- 2017-12-12
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for updates to the elution test methods for Tendril MRI leads.
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