BONNIE (TM) PTCA CATHERS
FDA premarket approval P880027/S052 · decided 1998-08-27
Approval details
- PMA number
- P880027
- Supplement
- S052
- 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
- 1997-09-09
- Decision date
- 1998-08-27
- Days to decision
- 352 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a new PTCA catheter. The device, as modified, will be marketed under the trade name Bypass Speedy(TM) Monorail(R) PTCA Dilatation Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpsoe of improving myocardial perfusion.
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