PMA P980037S085
- Device
- AngioJet Thrombectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S085
- Product code
- MCX
- Decision date
- 2021-08-11
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Change to incorporate a hydration step in the production of device pump components.
Current openFDA PMA Record#
- Device
- AngioJet Thrombectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S085
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2021-08-11
- Decision code
- OK30
- Date received
- 2021-07-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to incorporate a hydration step in the production of device pump components.