PMA P010020S020

Device
ACTICON NEOSPHINCTER
Applicant
Boston Scientific Corp
PMA number
P010020
Supplement
S020
Product code
MIP
Decision date
2010-12-22
Generic name
Implanted fecal incontinence device
Approval order statement
CHANGE TO THE CONTRACT MANUFACTURING SITE OF A COMPONENT.

Current openFDA PMA Record#

Device
ACTICON NEOSPHINCTER
Applicant
Boston Scientific Corp
PMA number
P010020
Supplement
S020
Product code
MIP
Generic name
Implanted fecal incontinence device
Decision date
2010-12-22
Decision code
OK30
Date received
2010-11-26
Supplement type
30-Day Notice
Approval order statement
CHANGE TO THE CONTRACT MANUFACTURING SITE OF A COMPONENT.