PMA P880027S056
- Device
- TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
- Applicant
- Boston Scientific
- PMA number
- P880027
- Supplement
- S056
- Product code
- LOX
- Decision date
- 2000-01-07
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- Revisions to the box and pouch labels for the Bonnie PTCA catheter.
Current openFDA PMA Record
- Device
- TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
- Applicant
- Boston Scientific
- PMA number
- P880027
- Supplement
- S056
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2000-01-07
- Decision code
- APPR
- Date received
- 1999-11-24
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Revisions to the box and pouch labels for the Bonnie PTCA catheter.