Atlas FDA

THE NEEDLE DESTROYER

FDA premarket approval P960018/S001 · decided 1998-11-17

Approval details

PMA number
P960018
Supplement
S001
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
THE NEEDLE DESTROYER
Generic name
Sharps needle destruction device
Applicant
Healthcare Products Plus, Inc.
Date received
1998-10-14
Decision date
1998-11-17
Days to decision
34 days
Decision code
APPR
Product code
MTV
Advisory committee
General Hospital
Expedited review
No
Location
Chicago, IL
Statement
Approval for a change to the battery charger and the associated instructions for use.

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.