Data / Medical devices / United States / Impulse Dynamics USA Inc
Impulse Dynamics USA Inc: FDA-registered device maker in Marlton, NJ, United States, 1 PMA approval
Impulse Dynamics USA Inc is registered with the FDA (registration 3012563838) in Marlton, NJ, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated March 21, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012563838
- Address
- 50 Lake Center Executive Parkway Suite 100, 401 Route 73 N, Bldg. 50, Marlton, NJ, United States, 08053
- Owner or operator
- Impulse Dynamics USA Inc (10032587)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 25, 2019
- Registered through
- 2026
- Brand names listed
- OPTIMIZER Smart Mini System, OPTIMIZER Smart System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implantable Pulse Generator | QFV | 3 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 21, 2019 | P180036 | OPTIMIZER Smart System | QFV | 43 | October 14, 2026 | accessdata.fda.gov |
Compare with other makers
Updated October 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.