|
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 | S003 |
Date Received | 10/05/1995 |
Decision Date | 03/01/1996 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE OF STERILIZATION FACILITY TO THE MEDICAL MANUFACTURING CORPORATION, ERIE, PENNSYLVANIA FOR THE PRODUCTS INCLUDING THE FALOPE-RING BAND:BOX OF 30 STERILE PROCEDURE KITS (REORDER NUJBER 000719-250), AND FALOPE-RING BAND: BOX OF 100 STERILE PROCEDURE KITS (REORDER NUMBER 001452-901) |