|
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 | S010 |
Date Received | 05/04/2010 |
Decision Date | 06/02/2010 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE TO THE SUPPLIER OF THREE COMPONENTS. |