MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA premarket approval P970031 · decided 1997-11-26
Approval details
- PMA number
- P970031
- Trade name
- MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic, Inc.
- Date received
- 1997-07-14
- Decision date
- 1997-11-26
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Approval for the Medtronic FREESTYLE(R) Aortic Root Bioprosthesis, Model 995; sizes 19, 21, 23, 25, 27 mm; implantation techniqures, subcoronary, full-root, and root inclusion; and the FREESTYLE(R) Aortic Obturators, Model 7990 and the Medtronic Handle, Model 0791. This device is a replacement heart valve and is indicated for the replacement of malfunctioning native or prosthetic aortic valves with the optio of aortic root replacement.
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510(k) clearances by this applicant
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|---|---|---|
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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