|
Device | ADIANA PERMANENT CONTRACEPTION SYSTEM |
Generic Name | Laparoscopic contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P070022 |
Supplement Number | S019 |
Date Received | 04/13/2011 |
Decision Date | 05/27/2011 |
Withdrawal Date
|
10/23/2012 |
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 OF A BACKUP STERILIZATION FACILITY LOCATED AT BIOTEST LABORATORIES, INC., IN BROOKLYN PARK, MINNESOTA. |