SCHNEIDER FREEHAND (TM) PTCA CATHETER
FDA premarket approval P880027/S027 · decided 1993-09-23
Approval details
- PMA number
- P880027
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SCHNEIDER FREEHAND (TM) PTCA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1993-03-09
- Decision date
- 1993-09-23
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
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