PMA P070022S020

Device
Adiana Permanent Contraception System
Applicant
HOLOGIC, INC.
PMA number
P070022
Supplement
S020
Decision date
2011-08-09

Current openFDA PMA Record

Device
ADIANA PERMANENT CONTRACEPTION SYSTEM
Applicant
Hologic, Inc.
PMA number
P070022
Supplement
S020
Product code
KNH
Generic name
Laparoscopic contraceptive tubal occlusion device
Decision date
2011-08-09
Decision code
APPR
Date received
2011-06-29
Approval order statement
APPROVAL FOR A CHANGE OF THE ACCEPTANCE CRITERIA FOR THE DEPLOYMENT FORCE EXERTED ON A POLYURETHANE RING IN THE ADIANA CATHETER.

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