PMA P070022S013

Device
ADIANA PERMANENT CONTRACEPTION SYSTEM
Applicant
Hologic, Inc.
PMA number
P070022
Supplement
S013
Product code
KNH
Decision date
2011-07-05
Generic name
Laparoscopic contraceptive tubal occlusion device
Approval order statement
APPROVAL FOR MINOR CHANGES TO A DAMPER TEST FIXTURE AND REVISION OF THE DAMPER ASSEMBLY PROCESS.

Current openFDA PMA Record

Device
ADIANA PERMANENT CONTRACEPTION SYSTEM
Applicant
Hologic, Inc.
PMA number
P070022
Supplement
S013
Product code
KNH
Generic name
Laparoscopic contraceptive tubal occlusion device
Decision date
2011-07-05
Decision code
APPR
Date received
2011-02-17
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR MINOR CHANGES TO A DAMPER TEST FIXTURE AND REVISION OF THE DAMPER ASSEMBLY PROCESS.

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