PMA P880065S006

Device: BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER
Applicant: Boston Scientific Corp
PMA number: P880065
Supplement: S006
Product code: LOT
Decision date: 2001-07-30
Classification: Cardiovascular
Generic name: PULSE-GENERATOR, PROGRAM MODULE
Approval order statement: APPROVAL FOR A MODIFICATION TO THE WARNING STATEMENT IN THE DIRECTIONS FOR USE MANUAL TO EXPAND ON THE POTENTIAL AFFECT OF RE-PROCESSING OR RE-STERILIZATION.

Current openFDA PMA Record#

Device: BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER
Applicant: Boston Scientific Corp
PMA number: P880065
Supplement: S006
Product code: LOT
Generic name: PULSE-GENERATOR, PROGRAM MODULE
Decision date: 2001-07-30
Decision code: APPR
Date received: 2001-07-12
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A MODIFICATION TO THE WARNING STATEMENT IN THE DIRECTIONS FOR USE MANUAL TO EXPAND ON THE POTENTIAL AFFECT OF RE-PROCESSING OR RE-STERILIZATION.