AngioJet Rheolythic Thrombectomy Catheter System
FDA premarket approval P980037/S088 · decided 2022-05-06
Approval details
- PMA number
- P980037
- Supplement
- S088
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AngioJet Rheolythic Thrombectomy Catheter System
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2022-04-07
- Decision date
- 2022-05-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Process devices using the reduced EtO S756 sterilization cycle at the BSC Coventry Rhode Island, BSC Galway Ireland, and Steris Tullamore Ireland facilities.
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|---|---|---|
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| WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853) | Boston Scientific Corp | 2015-11-20 |
| AXIOS Stent with Electrocautery Enhanced Delivery System (K150692) | Boston Scientific Corp | 2015-08-05 |
| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
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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 |