PMA P070022S001

Device
ADIANA PERMANENT CONTRACEPTION SYSTEM
Applicant
Hologic, Inc.
PMA number
P070022
Supplement
S001
Product code
KNH
Decision date
2009-10-20
Generic name
Laparoscopic contraceptive tubal occlusion device
Approval order statement
APPROVAL FOR CHANGING THE ADIANA INSTRUCTIONS FOR USE TO MAKE USE OF THE SPLIT INTRODUCER OPTIONAL.

Current openFDA PMA Record

Device
ADIANA PERMANENT CONTRACEPTION SYSTEM
Applicant
Hologic, Inc.
PMA number
P070022
Supplement
S001
Product code
KNH
Generic name
Laparoscopic contraceptive tubal occlusion device
Decision date
2009-10-20
Decision code
APPR
Date received
2009-08-04
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR CHANGING THE ADIANA INSTRUCTIONS FOR USE TO MAKE USE OF THE SPLIT INTRODUCER OPTIONAL.

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