ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
FDA premarket approval P980037/S039 · decided 2013-01-09
Approval details
- PMA number
- P980037
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2011-11-15
- Decision date
- 2013-01-09
- Days to decision
- 421 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR A NEW DEVICE, THE ANGIOJET ULTRA SYSTEM WITH THE DISTAFLEXTHROMBECTOMY SET WITH A 3 FRENCH DISTAL DIAMETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIOJET ULTRA SYSTEM WITH THE DISTAFLEX THROMBECTOMY SET AND IS INDICATED FOR REMOVING THROMBUS IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC CORONARY ARTERY OR SVG LESIONS IN VESSELS ¿ 2.0 MM IN DIAMETER PRIOR TO BALLOON ANGIOPLASTY OR STENT PLACEMENT.
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