FDA applicant
Siemens-Pacesetter, Inc.
FDA records 7 decisions for Siemens-Pacesetter, Inc. (Sylmar, CA) from 1992 to 1994: 7 510(k) clearances. Most are in product codes DTB (Permanent Pacemaker Electrode) and DTD (Pacemaker Lead Adaptor). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Siemens-Pacesetter, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Siemens-Pacesetter, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Siemens-Pacesetter, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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