SCHNEIDER MICROSOFTRAC/MONORAIL PICCOLINO
FDA premarket approval P880027/S011 · decided 1991-04-03
Approval details
- PMA number
- P880027
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SCHNEIDER MICROSOFTRAC/MONORAIL PICCOLINO
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1990-10-26
- Decision date
- 1991-04-03
- Days to decision
- 159 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
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