|
Device | ADIANA PERMANENT CONTRACEPTION SYSTEM |
Generic Name | Laparoscopic contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P070022 |
Supplement Number | S024 |
Date Received | 10/13/2011 |
Decision Date | 11/23/2011 |
Withdrawal Date
|
10/23/2012 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE ADIANA CATHETER TO INCREASE THE FLEXIBILITY FOR USE WITH HYSTEROSCOPES WITH ARTICULATING TIPS. |