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 | ESSURE SYSTEM |
Generic Name | Transcervical contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | BAYER PHARMA AG MOLLERSTRABE 178 BERLIN 13353 |
PMA Number | P020014 |
Supplement Number | S021 |
Date Received | 09/11/2008 |
Decision Date | 11/07/2008 |
Product Code |
HHS |
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 MINOR DESIGN CHANGES TO THE ESSURE SYSTEM, I.E., DIMENSIONAL SPECIFICATION OF THE DELIVERY WIRE HOLDER; CHANGE TO THE RELEASE BAND POSITIONING; AND A CHANGE TO THE HEAT SHRINK TUBING LENGTH. |
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