ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM
FDA premarket approval P980037/S009 · decided 2004-06-22
Approval details
- PMA number
- P980037
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2004-05-19
- Decision date
- 2004-06-22
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR CHANGES TO THE PUMP SET (ALSO CALLED THE PUMP SET PLUS) WHICH INCLUDED: 1) MODIFICATION TO THE PUMP OUTLET AND INLET FITTINGS; 2) CHANGES TO THE DEPTH OF THE CHECK BALL SEAT AND ELIMINATION OF THE CHECK BALL SPRING; 3) CHANGES TO THE PRIME SENSOR CUP; 4) CHANGES TO THE PISTON HEAD; 5) COLOR CHANGES TO THE LUER; AND 6) CHANGES TO THE PARATUBING ASSEMBLY.
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