PMA P870076S016

Device
FALOPE-RING BAND APPLICATOR KITS
Applicant
Gyrus Acmi, Inc.
PMA number
P870076
Supplement
S016
Product code
KNH
Decision date
2015-02-19
Classification
Laparoscopic Contraceptive Tubal Occlusion Device
Generic name
Laparoscopic contraceptive tubal occlusion device
Approval order statement
ADDITION OF A PACKAGE SEALING EQUIPMENT.

Current openFDA PMA Record#

Device
FALOPE-RING BAND APPLICATOR KITS
Applicant
Gyrus Acmi, Inc.
PMA number
P870076
Supplement
S016
Product code
KNH
Generic name
Laparoscopic contraceptive tubal occlusion device
Decision date
2015-02-19
Decision code
OK30
Date received
2015-01-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A PACKAGE SEALING EQUIPMENT.