Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
FDA premarket approval P140033/S006 · decided 2017-09-21
Approval details
- PMA number
- P140033
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-04-03
- Decision date
- 2017-09-21
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for MR Conditional labeling at 1.5T for ICD systems consisting of Ellipse ICDs, Durata, Optisure, and Tendril MRI leads.
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