BONNIE TM SLIDING RAIL PTCA CATHETERS
FDA premarket approval P880027/S055 · decided 1998-06-15
Approval details
- PMA number
- P880027
- Supplement
- S055
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BONNIE TM SLIDING RAIL PTCA CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1998-05-13
- Decision date
- 1998-06-15
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a modified package label, removing specification of the deflated profile.
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