MOSAIC PORCINE BIOPROSTHESIS
FDA premarket approval P990064/S002 · decided 2000-08-29
Approval details
- PMA number
- P990064
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MOSAIC PORCINE BIOPROSTHESIS
- Applicant
- Medtronic, Inc.
- Date received
- 2000-08-01
- Decision date
- 2000-08-29
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- CHANGE IN THE VENDOR OF THE POLYESTER YARN USED IN THE MANUFACTURE OF THE MOSAIC PORCINE BIOPROSTHESIS. ALSO, INCLUSION OF THE PMA PRODUCT IN THE "MASTER SUBMISSION" SUBMITTED APRIL 3, 1998 TO P970031/S006 FREESTYLE AORTIC BIOPROSTHESIS. THE INFORMATION CONTAINED IN THE "MASTER SUBMISSION" IS DIRECTLY APPLICABLE TO THE POLYESTER YARN VENDOR CHANGE.
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 |