Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S020 |
Date Received | 06/29/2011 |
Decision Date | 08/09/2011 |
Withdrawal Date
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10/23/2012 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Expedited Review Granted? | No |
Combination Product | No |
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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