MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA premarket approval P970031/S003 · decided 1998-06-16
Approval details
- PMA number
- P970031
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic, Inc.
- Date received
- 1997-12-24
- Decision date
- 1998-06-16
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Approval for the patient brochure for the device.
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510(k) clearances by this applicant
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|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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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 |