This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for a manufacturing site located at global machining industries, 28 xinchang road, 2nd floor, suzhou industrial park, suzhou 21500, china, manufacturing.
Device | Sharps Terminator |
Classification Name | Sharps Needle Destruction Device |
Generic Name | Sharps Needle Destruction Device |
Applicant | SHARPS TERMINATOR, LLC |
Date Received | 2017-05-25 |
Decision Date | 2018-02-16 |
PMA | P120018 |
Supplement | S001 |
Product Code | MTV |
Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
Advisory Committee | General Hospital |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | SHARPS TERMINATOR, LLC 6502 Slide Rd Suite 402 lubbock, TX 79401 |
Supplement Number | Date | Supplement Type |
---|---|---|
P120018 | Original Filing | |
S001 | 2017-05-25 | Normal 180 Day Track No User Fee |