Impulse Dynamics (Usa), Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Impulse Dynamics (Usa), Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QFV | Implantable Pulse Generator | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180036 | PMA | OPTIMIZER Smart System | 2019-03-21 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-01-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Impulse Dynamics (Usa), Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via QFV)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via QFV)
- C8009 — Removal of hypoglossal nerve neurostimulator array and pulse generator (via QFV)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Impulse Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Impulse Dynamics (Usa), Inc.?
FDA lists 0 510(k) clearances under the applicant name “Impulse Dynamics (Usa), Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Impulse Dynamics (Usa), Inc.?
The most frequent FDA product codes under this applicant name are QFV (Implantable Pulse Generator, 1).
Next steps
- See all 0 Impulse Dynamics (Usa), Inc. clearances with predicates and recalls
- Run predicate analysis for product code QFV, Impulse Dynamics (Usa), Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.