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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / P130030

PMA approved

REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE

Boston Scientific Corp · Mar 10, 2026 · P130030

FDA approved the REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE from Boston Scientific Corp on Mar 10, 2026 under P130030, an original premarket approval. The device falls under product code MAF, Stent, Coronary as a Class 3 device. The review panel was Cardiovascular.

Boston Scientific Corp has 8 other decisions in the tracker over the last 12 months: K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261488 (OBSIDIO Conformable Embolic), K262165 (FARADRIVE Steerable Sheath (M004PF21M402)), K262462 (TheraSphere 360 Y-90 Management Platform).

Questions & Answers

What did FDA approve under P130030?

P130030 is the FDA PMA for REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE, submitted by Boston Scientific Corp. FDA's decision date was Mar 10, 2026, under product code MAF (Stent, Coronary).

Who makes the REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE?

Boston Scientific Corp, based in Maple Grove, MN, is the applicant of record for P130030.

← All decisions in March 2026