|
Device | Falope-Ring® Band and Applicator Systems |
Generic Name | Laparoscopic contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | Gyrus ACMI, Inc. 136 TURNPIKE RD. SOUTHBOROUGH, MA 01772 |
PMA Number | P870076 |
Supplement Number | S026 |
Date Received | 04/16/2021 |
Decision Date | 05/11/2021 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the labeling to assure the risks associated with damaged packaging and components identified in the Design Failure Mode and Effects Analysis are addressed in the instructions for use. |