PMA P840040S048
- Device
- Sequel Convertible Rapid Exchange Ptca Catheter
- Applicant
- Boston Scientific Corp.
- PMA number
- P840040
- Supplement
- S048
- Decision date
- 1995-08-29
Current openFDA PMA Record
- Device
- SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P840040
- Supplement
- S048
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1995-08-29
- Decision code
- APPR
- Date received
- 1995-04-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR NEW PTCA CATHETER CREATED BY THE MODIFICATION OF THE SYNERGY II PTCA CATHETER MARKETED UNDER THE TRADE NAME:SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER