INCRAFT(R) AAA STENT GRAFT SYSTEM
FDA premarket approval P150002/S008 · decided 2020-09-23
Approval details
- PMA number
- P150002
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- INCRAFT(R) AAA STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cordis US Corporation
- Date received
- 2020-03-31
- Decision date
- 2020-09-23
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for updating the labeling to include 5-year INSPIRATION study data and minor editorial changes.
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