PMA P860019S159

Device: PTCA CATHETER
Applicant: Scimed Life Systems, Inc.
PMA number: P860019
Supplement: S159
Product code: LOX
Decision date: 2000-03-24
Classification: Catheters, Transluminal Coronary Angioplasty, Percutaneous
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for a labeling change that advises the user not to use the PTCA catheter if the proximal shaft has been bent or kinked.

Current openFDA PMA Record#

Device: PTCA CATHETER
Applicant: Scimed Life Systems, Inc.
PMA number: P860019
Supplement: S159
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 2000-03-24
Decision code: APPR
Date received: 2000-02-29
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a labeling change that advises the user not to use the PTCA catheter if the proximal shaft has been bent or kinked.