MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD
FDA premarket approval P080006/S004 · decided 2011-03-31
Approval details
- PMA number
- P080006
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2009-10-19
- Decision date
- 2011-03-31
- Days to decision
- 528 days
- Decision code
- APPR
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD. THE MODEL 4396 LEAD IS A 4 FRENCH, TRANSVENOUS, STEROID ELUTING, DUAL ELECTRODE, POLYURETHANE INSULATED, SINGLE COIL, STRAIGHT TIP, TINE FIXATION LEAD INTENDED FOR USE IN LEFT HEART CORONARY VEINS.
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