ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
FDA premarket approval P980037/S027 · decided 2009-03-19
Approval details
- PMA number
- P980037
- Supplement
- S027
- 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
- 2008-07-16
- Decision date
- 2009-03-19
- Days to decision
- 246 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE ANGIOJET ULTRA CONSOLE SOFTWARE VERSION V1.1.
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|---|---|---|
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