Calendar

Week of Sep 8, 2025

Sep 10, 2025device 510k339d agoMerit Medical System, Inc. — Surfacer Inside-Out Access Catheter System (510k cleared)MERIT MEDICAL SYSTEMS INC

Product code: QJH. Advisory committee: Cardiovascular. Type: Special

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Sep 10, 2025device 510k339d agoMr Surgical Solutions, LLC — OptiVu Shoulder (510k cleared)

Product code: SBF. Advisory committee: Neurology. Type: Special

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Sep 10, 2025device 510k339d agoFisher & Paykel Healthcare, Ltd. — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full (510k cleared)

Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional

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Sep 10, 2025device 510k339d agoBeckman Coulter, Inc. — iQ200 Series (510k cleared)

Product code: LKM. Advisory committee: Hematology. Type: Special

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Sep 10, 2025device 510k339d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Sep 10, 2025device 510k339d agoVizionfocus, Inc. — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (510k cleared)

Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

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Sep 10, 2025device 510k339d agoAngiowave Imaging, Inc. — AngioWaveNet (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

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Sep 10, 2025device 510k339d agoPollogen, Ltd. — OptiLUV Device (510k cleared)

Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional

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Sep 10, 2025device 510k339d agoTimpel S.A. — Enlight 2100 (TPL-E2103-0) (510k cleared)TIM S.A.

Product code: QEB. Advisory committee: Anesthesiology. Type: Traditional

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Sep 10, 2025device pma339d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Foldable Acrylic IOL with OptiEdge (PMA supplement)JOHNSON & JOHNSON

Supplement type: Normal 180 Day Track No User Fee. Product code: HQL. Advisory committee: OP. Decision: APPR

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Sep 10, 2025device pma339d agoMedtronic Neuromodulation — InterStim® Therapy System (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: APPR

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Sep 10, 2025device pma339d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30

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Sep 10, 2025device pma339d agoABBOTT MEDICAL — CardioMEMSTM HF System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30

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Sep 10, 2025device pma339d agoBeaver Visitec International, Inc. — FINEVISION HP Trifocal IOLs (PMA)

Product code: HQL. Advisory committee: OP. Decision: APPR

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Sep 10, 2025device pma339d agoBolton Medical, Inc. — RelayPro Thoracic Stent-Graft System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

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Sep 10, 2025device pma339d agoAbbott Molecular, Inc. — Alinity m HR HPV (PMA supplement)

Supplement type: Panel Track. Product code: MAQ. Advisory committee: MI. Decision: APPR

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Sep 10, 2025device pma339d agoJohnson & Johnson Surgical Vision, Inc. — SENSAR Soft Acrylic Posterior Chamber IOL, SENSAR 1-piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS (PMA supplement)JOHNSON & JOHNSON

Supplement type: Normal 180 Day Track No User Fee. Product code: HQL. Advisory committee: OP. Decision: APPR

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Sep 10, 2025device pma339d agoBiosense Webster, Inc. — VARIPULSE Catheter (PMA supplement)

Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30

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Sep 10, 2025device pma339d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Multifocal 3-Piece IOL (PMA supplement)JOHNSON & JOHNSON

Supplement type: Normal 180 Day Track No User Fee. Product code: MFK. Advisory committee: OP. Decision: APPR

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Sep 10, 2025device pma339d agoMedtronic Neuromodulation — InterStim® Therapy System (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: APPR

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