PMA P980037S094
- Device
- AngioJet Thrombectomy System - AutoElite Console
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S094
- Product code
- MCX
- Decision date
- 2025-05-01
- Classification
- Cardiovascular
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- for the AutoElite Console and its manufacturing at a new site
Current openFDA PMA Record#
- Device
- AngioJet Thrombectomy System - AutoElite Console
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S094
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2025-05-01
- Decision code
- APPR
- Date received
- 2024-06-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for the AutoElite Console and its manufacturing at a new site