ANCURE ENDOGRAFT SYSTEM/ILIAC BALLOON CATHETER
FDA premarket approval P990017/S006 · decided 2000-04-14
Approval details
- PMA number
- P990017
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANCURE ENDOGRAFT SYSTEM/ILIAC BALLOON CATHETER
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Boston Scientific Corp
- Date received
- 2000-03-15
- Decision date
- 2000-04-14
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the addition of a hydrophilic coating with the trade name HYDRACOAT to the outer surface of the ANCURE Delivery Catheter jacket.
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