Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceFalope Ring Band and Applicator Systems
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantGyrus ACMI, Inc.
136 TURNPIKE RD.
SOUTHBOROUGH, MA 01772
PMA NumberP870076
Supplement NumberS027
Date Received04/21/2021
Decision Date05/19/2021
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Update to sterilization parameters for the reduction of gas concentration in the ethylene oxide (EO) sterilization process.
-
-