Mosaic Bioprosthesis, Models 305 and 310
FDA premarket approval P990064/S069 · decided 2017-08-09
Approval details
- PMA number
- P990064
- Supplement
- S069
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Mosaic Bioprosthesis, Models 305 and 310
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2017-07-10
- Decision date
- 2017-08-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Implement additional test samples for solution chemistry and sterility as part of the routine monitoring and lot release performed for terminal liquid sterilization.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |