PMA P070022S021

Device
Adiana Permanent Contraception System
Applicant
HOLOGIC, INC.
PMA number
P070022
Supplement
S021
Decision date
2011-07-26

Current openFDA PMA Record

Device
ADIANA PERMANENT CONTRACEPTION SYSTEM
Applicant
Hologic, Inc.
PMA number
P070022
Supplement
S021
Product code
KNH
Generic name
Laparoscopic contraceptive tubal occlusion device
Decision date
2011-07-26
Decision code
OK30
Date received
2011-07-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGES TO THE MANUFACTURING AND SOLDERING PROCESS OF A COMPONENT OF THE DEVICE.

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