MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD; ATTAIN ABILITY PLUS MRI SURESCAN LEAD MODEL 4296; ATTAIN ABILITY STRAIGHT MRI
FDA premarket approval P080006/S093 · decided 2016-10-25
Approval details
- PMA number
- P080006
- Supplement
- S093
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD; ATTAIN ABILITY PLUS MRI SURESCAN LEAD MODEL 4296; ATTAIN ABILITY STRAIGHT MRI
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2016-05-03
- Decision date
- 2016-10-25
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility.
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