BONNIE SLIDING RAIL PTCA CATHETERS
FDA premarket approval P880027/S053 · decided 1997-11-21
Approval details
- PMA number
- P880027
- Supplement
- S053
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BONNIE SLIDING RAIL PTCA CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1997-10-24
- Decision date
- 1997-11-21
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a 3 and 1/2 year shelf life for the Bonnie(TM) Slidng Rail Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.
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