PMA P980037S093
- Device
- AngioJet Ultra 5000A Console
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S093
- Product code
- MCX
- Decision date
- 2024-08-05
- Classification
- Cardiovascular
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- labeling changes to the AngioJet Ultra 5000A Console Instructions for Use
Current openFDA PMA Record#
- Device
- AngioJet Ultra 5000A Console
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S093
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2024-08-05
- Decision code
- APPR
- Date received
- 2024-05-09
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- labeling changes to the AngioJet Ultra 5000A Console Instructions for Use