MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD
FDA premarket approval P080006/S006 · decided 2012-10-04
Approval details
- PMA number
- P080006
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2010-01-29
- Decision date
- 2012-10-04
- Days to decision
- 979 days
- Decision code
- APPR
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR COMPONENT LEVEL ANALYTICAL TESTING FOR RELEASE OF THE MODEL 4196, 4296 AND 4396.
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