BONNIE (TM) PTCA CATHERS
FDA premarket approval P880027/S050 · decided 1997-10-24
Approval details
- PMA number
- P880027
- Supplement
- S050
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BONNIE (TM) PTCA CATHERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1997-06-09
- Decision date
- 1997-10-24
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for 15 mm length models of the Bonnie(TM) PTCA Catheter. The new models will be marketed under the trade name Bonnie(TM) Monorail(R) Percutaneous Transluminal Coronary Agnioplasty (PTCA) Catheters and are indicated for balloon dilatation of the stenotic portion of a coronary arteyr or bypass graft stenosis for the purpose of improving myocardial perfusion.
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