PMA P880027S043
- Device
- Asuka(tm) And Asuka(tm) Longy Ptca Catheters
- Applicant
- BOSTON SCIENTIFIC
- PMA number
- P880027
- Supplement
- S043
- Decision date
- 1997-02-19
Current openFDA PMA Record
- Device
- ASUKA(TM) AND ASUKA(TM) LONGY PTCA CATHETERS
- Applicant
- Boston Scientific
- PMA number
- P880027
- Supplement
- S043
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-02-19
- Decision code
- APPR
- Date received
- 1997-01-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- INCREASE IN RATED BURST PRESSURE FOR THE SCHNEIDER ASUKA(TM) AND ASUKA(TM) LONGY PTCA CATHETERS