CHANGES TO ALPHA /STREAK ADD BALLOON LENGTHS
FDA premarket approval P810046/S125 · decided 1993-07-07
Approval details
- PMA number
- P810046
- Supplement
- S125
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CHANGES TO ALPHA /STREAK ADD BALLOON LENGTHS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1992-06-01
- Decision date
- 1993-07-07
- Days to decision
- 401 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
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