ATTAIN STARFIX MODEL 4195 LEAD
FDA premarket approval P060039 · decided 2008-06-13
Approval details
- PMA number
- P060039
- Trade name
- ATTAIN STARFIX MODEL 4195 LEAD
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2006-12-27
- Decision date
- 2008-06-13
- Days to decision
- 534 days
- Decision code
- APPR
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ATTAIN STARFIX MODEL 4195 LEAD. THE ATTAIN STARFIX MODEL 4195 STEROID ELUTING, TRANSVENOUS LEAD WITH DEPLOYABLE LOBE FIXATION IS INTENDED FOR CHRONIC PACING AND SENSING OF THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED IN CONJUNCTION WITH A COMPATIBLE IMPLANTABLE PULSE GENERATOR OR IMPLANTABLE CARDIAC DEFIBRILLATOR.
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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