AngioJet Ultra 5000A Console
FDA premarket approval P980037/S093 · decided 2024-08-05
Approval details
- PMA number
- P980037
- Supplement
- S093
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AngioJet Ultra 5000A Console
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2024-05-09
- Decision date
- 2024-08-05
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- labeling changes to the AngioJet Ultra 5000A Console Instructions for Use
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