MEDTRONIC 4195 ATTAIN STARFIX MODEL 4195 LV LEAD
FDA premarket approval P060039/S062 · decided 2014-09-12
Approval details
- PMA number
- P060039
- Supplement
- S062
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- MEDTRONIC 4195 ATTAIN STARFIX MODEL 4195 LV LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2014-08-22
- Decision date
- 2014-09-12
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL OF THE REQUEST TO CLOSE THE CHRONIC EXTRACTION POST-APPROVAL STUDY FOR THE DEVICE.
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