HANCOCK II PORCINE BIOPROSTHESIS MODEL T505 (AORTIC)
FDA premarket approval P980043/S002 · decided 2002-10-28
Approval details
- PMA number
- P980043
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HANCOCK II PORCINE BIOPROSTHESIS MODEL T505 (AORTIC)
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2002-05-01
- Decision date
- 2002-10-28
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE VALVE HOLDERS FOR THE HANCOCK II BIOPROSTHESIS. THE HOLDERS ARE TO BE USED WITH THE FOLLOWING APPROVED VALVE MODELS AND SIZES: HANCOCK II PORCINE BIOPROSTHESIS, MODEL T505 (AORTIC, SIZES 21, 23, 25, 27, AND 29 MM. THESE AORTIC VALVES ARE INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| 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 |