PMA P980037S082
- Device
- AngioJet Rheolytic Thrombectomy Catheter
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S082
- Product code
- MCX
- Decision date
- 2020-10-29
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Change in endotoxin sampling plan.
Current openFDA PMA Record#
- Device
- AngioJet Rheolytic Thrombectomy Catheter
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S082
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2020-10-29
- Decision code
- OK30
- Date received
- 2020-10-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in endotoxin sampling plan.