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57 catalysts · 24 approval · 11 recall · 10 device 510k · 9 device pma · 2 device recall · 1 grant
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57 catalysts · 24 approval · 11 recall · 10 device 510k · 9 device pma · 2 device recall · 1 grant
Supplement type: Normal 180 Day Track No User Fee. Product code: PLJ. Advisory committee: SU. Decision: APPR
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
PIE PAK Models: P2HC-A, P2HC-S, P2HC — Reason: Lack of 510K clearance — Status: Ongoing
PIE Trolley System Model: 2005 — Reason: Lack of 510K clearance — Status: Ongoing
GM grant. $196,875. PI: Stephania A Cormier