POSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
FDA premarket approval P980037/S020 · decided 2007-03-28
Approval details
- PMA number
- P980037
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2006-09-29
- Decision date
- 2007-03-28
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE SPIROFLEX VG CATHETER THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM: SPIROFLEX VG RAPID EXCHANGE RHEOLYTIC THROMBECTOMY CATHETER AND IS INDICATED FOR REMOVING THROMBUS IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC CORONARY ARTERY OR SAPHENOUS VEIN GRAFT LESIONS IN VESSELS >= 3 MM IN DIAMETER PRIOR TO BALLOON ANGIOPLASTY OR STENT PLACEMENT.
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