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20,363 catalysts · 4,728 grant · 3,369 8k filing · 3,076 device 510k · 2,774 approval · 2,000 device pma · 2,000 device recall
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20,363 catalysts · 4,728 grant · 3,369 8k filing · 3,076 device 510k · 2,774 approval · 2,000 device pma · 2,000 device recall
ACCOLADE DR SL (Model L301) — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
ACCOLADE DR EL (Model L321) — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
Model Number S701 ALTRUA 2 SR SL Pacemaker — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
Model Number L111, ESSENTIO DR SL MRI Pacemaker — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
ACCOLADE SR SL (Model L300) — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
Model Number U125, VALITUDE CRT-P EL — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
Model Number L100, ESSENTIO SR SL Pacemaker — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
ACCOLADE SR SL MRI (Model L310) — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
PROPONENT DR SL (Model L201) — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
Model Number S722, ALTRUA 2 DR EL Pacemaker — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
ACCOLADE DR SL MRI (Model L311) — Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). — Status: Ongoing
Product code: LTT. Advisory committee: Microbiology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: QSM. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: SFN. Advisory committee: Neurology. Type: Direct
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: NDC. Advisory committee: Anesthesiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Sponsor: RHYTHM. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NCD. Advisory committee: MI. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MIH. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: OTL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
i-STAT EG6+ cartridge. List Number: 03P77-25. — Reason: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2. — Status: Ongoing
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile — Reason: Labeling includes shelf life that has not been validated. — Status: Ongoing
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile — Reason: Labeling includes shelf life that has not been validated. — Status: Ongoing
i-STAT CG4+ cartridge (white). List Number: 03P85-25. — Reason: Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2. — Status: Ongoing
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q — Reason: The kits contain certain lots of cannula products where the catheter may not retain its shape. — Status: Ongoing
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile — Reason: Labeling includes shelf life that has not been validated. — Status: Ongoing
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300 — Reason: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2. — Status: Ongoing
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile — Reason: Labeling includes shelf life that has not been validated. — Status: Ongoing
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile — Reason: Labeling includes shelf life that has not been validated. — Status: Ongoing