PMA P840040S050

Device: SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER
Applicant: Boston Scientific Corp
PMA number: P840040
Supplement: S050
Product code: LOX
Decision date: 1995-10-19
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR REVISED LABELING TO ADDRESS OUR PTCA LABELING LETTER OF JAN 7, 1995 AND CHANGE THE CORPORATE NAME ON YOUR LABELING FROM MANSFIELD/BOSTON SCIENTIFIC CORP TO SCIMED/BOSTON SCIENTIFIC CORP

Current openFDA PMA Record

Device: SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER
Applicant: Boston Scientific Corp
PMA number: P840040
Supplement: S050
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1995-10-19
Decision code: APPR
Date received: 1995-09-06
Supplement type: Normal 180 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 JAN 7, 1995 AND CHANGE THE CORPORATE NAME ON YOUR LABELING FROM MANSFIELD/BOSTON SCIENTIFIC CORP TO SCIMED/BOSTON SCIENTIFIC CORP