Impulse Dynamics USA Inc
Marlton, NJ, US
Impulse Dynamics USA Inc appears in FDA device records in Marlton, NJ. FDA records list no 510(k) clearances, 42 PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012563838 | 3012563838 | Impulse Dynamics USA Inc | 50 Lake Center Executive Parkway, Marlton, NJ 08053 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1173-2024 | OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite | OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain