PMA P880065S005

Device: AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER
Applicant: Boston Scientific Corp
PMA number: P880065
Supplement: S005
Product code: LOT
Decision date: 2001-03-27
Classification: Cardiovascular
Generic name: PULSE-GENERATOR, PROGRAM MODULE
Approval order statement: CHANGE FROM AN INTERNAL PARTICULATE MAXIMUM LEVEL TO AN INTERNAL PARTICULATE ACTION LEVEL OF 75,000 PARTICLES >=10 MICRONS FOR THE FINISHED PRODUCT.

Current openFDA PMA Record#

Device: AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER
Applicant: Boston Scientific Corp
PMA number: P880065
Supplement: S005
Product code: LOT
Generic name: PULSE-GENERATOR, PROGRAM MODULE
Decision date: 2001-03-27
Decision code: OK30
Date received: 2001-02-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE FROM AN INTERNAL PARTICULATE MAXIMUM LEVEL TO AN INTERNAL PARTICULATE ACTION LEVEL OF 75,000 PARTICLES >=10 MICRONS FOR THE FINISHED PRODUCT.