PMA P980037S071
- Device
- AngioJet Rheolytic Thrombectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S071
- Product code
- MCX
- Decision date
- 2018-11-06
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Removal of an in-process inspection of a non-critical component.
Current openFDA PMA Record#
- Device
- AngioJet Rheolytic Thrombectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S071
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2018-11-06
- Decision code
- OK30
- Date received
- 2018-10-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of an in-process inspection of a non-critical component.