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17 catalysts · 7 device 510k · 6 device pma · 4 approval
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17 catalysts · 7 device 510k · 6 device pma · 4 approval
Sponsor: APOTEX INC. Form: TABLET. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL
Sponsor: KAMAT. Form: SOLUTION. Route: ORAL
Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NRA. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: QCA. Advisory committee: NE. Decision: APPR
Product code: FMF. Advisory committee: General Hospital. Type: Special
Product code: OVD. Advisory committee: Orthopedic. Type: Special
Product code: MJN. Advisory committee: Cardiovascular. Type: Traditional
Product code: SFE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: HTY. Advisory committee: Orthopedic. Type: Traditional
Product code: KFM. Advisory committee: Cardiovascular. Type: Traditional