INCRAFT AAA Stent Graft System
FDA premarket approval P150002/S001 · decided 2019-03-26
Approval details
- PMA number
- P150002
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- INCRAFT AAA Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cordis US Corporation
- Date received
- 2019-01-25
- Decision date
- 2019-03-26
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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