PMA P870076S025

Device
Falope Ring Bands
Applicant
Gyrus Acmi, Inc.
PMA number
P870076
Supplement
S025
Product code
KNH
Decision date
2020-07-02
Generic name
Laparoscopic contraceptive tubal occlusion device
Approval order statement
Falope-Ring Band (FRB-30) sterilization site change from Viant to Steris, Inc. in Minneapolis, Minneapolis.

Current openFDA PMA Record#

Device
Falope Ring Bands
Applicant
Gyrus Acmi, Inc.
PMA number
P870076
Supplement
S025
Product code
KNH
Generic name
Laparoscopic contraceptive tubal occlusion device
Decision date
2020-07-02
Decision code
OK30
Date received
2020-04-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Falope-Ring Band (FRB-30) sterilization site change from Viant to Steris, Inc. in Minneapolis, Minneapolis.