|
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 | S014 |
Date Received | 10/20/2014 |
Decision Date | 11/17/2014 |
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 LABELING CLARIFICATIONS REGARDING NOT LOADING DEVICES MORE THAN THIRTY MINUTES BEFORE USE, AND REDUCING LANGUAGES IN DEVICE LABELING TO ONLY ENGLISH AND FRENCH. |