PMA P840040S049
- Device
- Sequel Convertible Rapid Exchange Ptca Catheter
- Applicant
- Boston Scientific Corp.
- PMA number
- P840040
- Supplement
- S049
- Decision date
- 1995-10-19
Current openFDA PMA Record
- Device
- SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P840040
- Supplement
- S049
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1995-10-19
- Decision code
- APPR
- Date received
- 1995-09-05
- Supplement type
- THIRTY DAY TRACK
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED LABELING TO ADDRESS OUR PTCA LABELING LETTER OF JANUARY 7, 1995, AND CHANGE THE CORPORATE NAME ON YOUR LABELING FROM MANSFIELD/BOSTON SCIENTIFIC CORPORATION TO SCIMED/BOSTON SCIENTIFIC CORPORATION