ANCURE(TM) TUBE SYSTEM, ANCURE(TM) BIFURCATED SYSTEM
FDA premarket approval P990017 · decided 1999-09-28
Approval details
- PMA number
- P990017
- Trade name
- ANCURE(TM) TUBE SYSTEM, ANCURE(TM) BIFURCATED SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Boston Scientific Corp
- Date received
- 1999-03-15
- Decision date
- 1999-09-28
- Days to decision
- 197 days
- Decision code
- APWD
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- St Paul, MN
- Statement
- Approval for the ANCURE Tube and Bifurcated Systems and the ANCURE Iliac Balloon Catheter (9 mm to 14 mm sizes). This device has the following indications for use: The ANCURE(TM) Tube System is indicated for the endovascular treatment of infrarenal abdominal aortic aneurysms (AAA) in patients having adequate iliac/femoral access, infrarenal non-aneurysmal neck length of at least 15 mm and a diameter of no greater than 26mm, distal segment neck length of 12mm and diameter of no greater than 26mm,
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510(k) clearances by this applicant
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|---|---|---|
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |