PMA P880065S003

Device: MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
Applicant: Boston Scientific Corp
PMA number: P880065
Supplement: S003
Product code: LOT
Decision date: 1997-09-08
Generic name: PULSE-GENERATOR, PROGRAM MODULE
Approval order statement: Approval for: 1) an alternate manufacturing and sterilization facility; 2) use of the Oxyfume 2000 sterilant gas mixture for sterilization; 3) use of a parametric release instead of the biological indicators product release process; and 4) use of a revised labeling format, which replaces the Mansfield name with the SCIMED(R) name.

Current openFDA PMA Record#

Device: MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
Applicant: Boston Scientific Corp
PMA number: P880065
Supplement: S003
Product code: LOT
Generic name: PULSE-GENERATOR, PROGRAM MODULE
Decision date: 1997-09-08
Decision code: APPR
Date received: 1997-03-05
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for: 1) an alternate manufacturing and sterilization facility; 2) use of the Oxyfume 2000 sterilant gas mixture for sterilization; 3) use of a parametric release instead of the biological indicators product release process; and 4) use of a revised labeling format, which replaces the Mansfield name with the SCIMED(R) name.