|
Device | FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM |
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 | S007 |
Date Received | 07/27/1998 |
Decision Date | 03/02/1999 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for dimensional and design changes of the Falope-Ring(R) Applicators. |