FdaApprovalPulse: PMA supplement (device change), page 4 of 4
Records 351 to 367 of the 367 newest listed for this hub. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
| Record | Product | Approval | Decided |
|---|---|---|---|
| Foundation Medicine, Inc. | FoundationOne CDx | PMA supplement (device change) | 2026-05-12 |
| Keri Medical SA | TOUCH® CMC 1 Prosthesis | PMA supplement (device change) | 2026-05-12 |
| Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) | PMA supplement (device change) | 2026-05-11 |
| Mentor Corp. | MENTOR MemoryGel Enhance Breast Implants | PMA supplement (device change) | 2026-05-11 |
| Foundation Medicine, Inc. | FoundationOne® CDx | PMA supplement (device change) | 2026-05-08 |
| Foundation Medicine, Inc. | FoundationOne®Liquid CDx | PMA supplement (device change) | 2026-05-08 |
| QIAGEN GmbH | QIAGEN therascreen® FGFR RGQ RT-PCR Kit | PMA supplement (device change) | 2026-05-06 |
| Medtronic, Inc. | CareLink SmartSync Adapta Versa Sensia Application (D00U014) | PMA supplement (device change) | 2026-05-06 |
| AtriCure, Inc. | Synergy Ablation System | PMA supplement (device change) | 2026-05-06 |
| Medtronic, Inc. | CareLink SmartSync Platform Application (M01A01); CareLink SmartSync Common Application (M01A02); CareLink SmartSync Hos | PMA supplement (device change) | 2026-05-06 |
| AtriCure, Inc. | EPi-Sense and EPi-Sense ST Guided Coagulation System | PMA supplement (device change) | 2026-05-06 |
| Physio-Control, Inc. | LIFEPAK® 15 monitor/defibrillator | PMA supplement (device change) | 2026-05-06 |
| Neuros Medical, Inc. | Altius® Direct Electrical Nerve Stimulation System | PMA supplement (device change) | 2026-05-05 |
| Abbott | CentriMag Circulatory Support System | PMA supplement (device change) | 2026-05-04 |
| Merz North America, Inc. | Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine | PMA supplement (device change) | 2026-05-03 |
| Guardant Health, Inc. | Guardant360® CDx | PMA supplement (device change) | 2026-05-01 |
| Boston Scientific Corporation | Ranger Paclitaxel-Coated PTA Balloon Catheter | PMA supplement (device change) | 2026-05-01 |
All FdaApprovalPulse record reports