AngioJet Rheolytic Thrombectomy System
FDA premarket approval P980037/S065 · decided 2017-06-02
Approval details
- PMA number
- P980037
- Supplement
- S065
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AngioJet Rheolytic Thrombectomy System
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2017-04-17
- Decision date
- 2017-06-02
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a manufacturing site located at BSC Maple Grove, Two Scimed Place Maple Grove, Minnesota for final sterilization packaging and labeling.
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