AngioJet Ultra Thrombectomy System Console
FDA premarket approval P980037/S068 · decided 2018-02-08
Approval details
- PMA number
- P980037
- Supplement
- S068
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AngioJet Ultra Thrombectomy System Console
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2018-01-10
- Decision date
- 2018-02-08
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for changes to the Directions for Use (DFU) Operators Manual to enhance the safety of the device.
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510(k) clearances by this applicant
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|---|---|---|
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |