ANEURX AAADVANTAGE XCELERANT HYDRO DELIVERY SYSTEM
FDA premarket approval P990020/S028 · decided 2007-12-06
Approval details
- PMA number
- P990020
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANEURX AAADVANTAGE XCELERANT HYDRO DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2007-11-14
- Decision date
- 2007-12-06
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE ADDITION OF A HYDROPHILIC COATING TO THE DEVICE.
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