PMA P880027S050
- Device
- Bonnie (tm) Ptca Cathers
- Applicant
- BOSTON SCIENTIFIC
- PMA number
- P880027
- Supplement
- S050
- Decision date
- 1997-10-24
Current openFDA PMA Record
- Device
- BONNIE (TM) PTCA CATHERS
- Applicant
- Boston Scientific
- PMA number
- P880027
- Supplement
- S050
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-10-24
- Decision code
- APPR
- Date received
- 1997-06-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.