PMA P880027S055
- Device
- BONNIE TM SLIDING RAIL PTCA CATHETERS
- Applicant
- Boston Scientific
- PMA number
- P880027
- Supplement
- S055
- Product code
- LOX
- Decision date
- 1998-06-15
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- Approval for a modified package label, removing specification of the deflated profile.
Current openFDA PMA Record
- Device
- BONNIE TM SLIDING RAIL PTCA CATHETERS
- Applicant
- Boston Scientific
- PMA number
- P880027
- Supplement
- S055
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1998-06-15
- Decision code
- APPR
- Date received
- 1998-05-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a modified package label, removing specification of the deflated profile.