|
Device | ACMI FALOPE RING BAND |
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 | S008 |
Date Received | 08/18/2006 |
Decision Date | 05/24/2007 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT GYRUS ACMI CORPORATION, MAPLE GROVE MINNESOTA TO MANUFACTURE THE FALOPE RING BAND AND THE FALOPE RING BAND DISPOSABLE APPLICATOR KITS. |