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32 catalysts · 17 device pma · 11 device 510k · 4 approval
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32 catalysts · 17 device pma · 11 device 510k · 4 approval
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Supplement type: Normal 180 Day Track No User Fee. Product code: OAD. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OUT. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MCX. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: SBB. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OAD. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MTG. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30
Supplement type: Real-Time Process. Product code: FHW. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: LPB. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: PJY. Advisory committee: OR. Decision: APPR
Product code: FLE. Advisory committee: General Hospital. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JDQ. Advisory committee: Orthopedic. Type: Traditional
Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional
Product code: FMZ. Advisory committee: General Hospital. Type: Traditional
Product code: NLQ. Advisory committee: Unknown. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PMN. Advisory committee: Microbiology. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Dual Track
Product code: NPL. Advisory committee: Dental. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional