PMA P880027S054
- Device
- BONNIE TM SLIDING RAIL PTCA CATHETERS
- Applicant
- Boston Scientific
- PMA number
- P880027
- Supplement
- S054
- Product code
- LOX
- Decision date
- 1997-12-23
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- Approval for modified labeling for the Magic Help Threader which is packaged with the Bonnie(TM) PTCA Catheters.
Current openFDA PMA Record
- Device
- BONNIE TM SLIDING RAIL PTCA CATHETERS
- Applicant
- Boston Scientific
- PMA number
- P880027
- Supplement
- S054
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-12-23
- Decision code
- APPR
- Date received
- 1997-11-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modified labeling for the Magic Help Threader which is packaged with the Bonnie(TM) PTCA Catheters.