ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD
FDA premarket approval P080006/S068 · decided 2014-08-01
Approval details
- PMA number
- P080006
- Supplement
- S068
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2014-04-01
- Decision date
- 2014-08-01
- Days to decision
- 122 days
- Decision code
- APPR
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD, INDICATED FOR CHRONIC PACING IN THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED WITH A COMPATIBLE MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY (CRT) SYSTEM.
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