Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)
FDA premarket approval P810002/S123 · decided 2024-07-02
Approval details
- PMA number
- P810002
- Supplement
- S123
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-05-30
- Decision date
- 2024-07-02
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- a change in manufacturing of the Tyvek Lids for the inner and outer trays in the packaging system
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510(k) clearances by this applicant
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|---|---|---|
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
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| OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459) | ABBOTT MEDICAL | 2026-04-24 |
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |