MEDTRONIC ATTAIN STARFIX MODEL 4195 LEADS
FDA premarket approval P060039/S056 · decided 2014-08-04
Approval details
- PMA number
- P060039
- Supplement
- S056
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- MEDTRONIC ATTAIN STARFIX MODEL 4195 LEADS
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2014-02-07
- Decision date
- 2014-08-04
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR UPDATING THE HEARTMATE II LVAS INSTRUCTIONS FOR USE TO INCLUDE THE POST-APPROVAL STUDY RESULTS FOR THE DESTINATION THERAPY INDICATION AND TO ADD A DISCUSSION ON PUMP THROMBOSIS.
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510(k) clearances by this applicant
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|---|---|---|
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| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |