BONNIE TM SLIDING RAIL PTCA CATHETERS
FDA premarket approval P880027/S054 · decided 1997-12-23
Approval details
- PMA number
- P880027
- Supplement
- S054
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BONNIE TM SLIDING RAIL PTCA CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1997-11-12
- Decision date
- 1997-12-23
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for modified labeling for the Magic Help Threader which is packaged with the Bonnie(TM) PTCA Catheters.
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