SCHNEIDER FREEHAND(R) PTCA CATHETERS
FDA premarket approval P880027/S033 · decided 1995-03-24
Approval details
- PMA number
- P880027
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SCHNEIDER FREEHAND(R) PTCA CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1994-07-01
- Decision date
- 1995-03-24
- Days to decision
- 266 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
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