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13,489 catalysts · 3,350 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event
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13,489 catalysts · 3,350 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event
NS grant. $245,687. PI: Sara J Hussain
AI grant. $85,360. PI: Kurtis Matthew Host
AI grant. $103,760. PI: Conor James McMeniman
DK grant. $20,000. PI: FOUAD R KANDEEL
AI grant. $48,395. PI: Isabel Lamb-Echegaray
AI grant. $75,520. PI: Shyra Wilde
AI grant. $75,052. PI: Rachel Lucy Fay
Supplement type: Normal 180 Day Track No User Fee. Product code: OUT. Advisory committee: NE. Decision: APPR
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. — Reason: A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery. — Status: Ongoing
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS. Form: TABLET. Route: ORAL
Sponsor: MYLAN. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: SPH ZHONGXI PHARM. Form: TABLET. Route: ORAL
Sponsor: UCB INC. Form: FOR SOLUTION. Route: ORAL
Sponsor: BRECKENRIDGE. Form: CAPSULE. Route: ORAL
Product code: PAB. Advisory committee: Microbiology. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: MZP. Advisory committee: Microbiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: EIA. Advisory committee: Dental. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: LOK. Advisory committee: IM. Decision: APPR
Food Intolerance Test Small — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Vitamin D-Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Candida Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Organic Acids Profile Test Large — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Allergy Test IgE — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Allergy test Small — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
GI Microbiome Profile XL — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Illegally Marketed — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
HPV Antigen Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Sperm Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Mycoplasma test, IgG and IgM — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Parasite Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Adrenal Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Neurotransmitters Plus — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Pollen Allergy Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. — Reason: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. — Status: Ongoing