PMA P880027S052
- Device
- Bonnie (tm) Ptca Cathers
- Applicant
- BOSTON SCIENTIFIC
- PMA number
- P880027
- Supplement
- S052
- Decision date
- 1998-08-27
Current openFDA PMA Record
- Device
- BONNIE (TM) PTCA CATHERS
- Applicant
- Boston Scientific
- PMA number
- P880027
- Supplement
- S052
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1998-08-27
- Decision code
- APPR
- Date received
- 1997-09-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.