Prollenium Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Prollenium Medical Technologies, 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 |
|---|---|---|---|
| LMH | Implant, Dermal, For Aesthetic Use | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160042 | PMA | REVANESSE ULTRA | 2017-08-04 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-11-15.
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.
Device clinical trials
An industry sponsor named Prollenium Medical Technologies, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04927052: A Study to Evaluate the Safety and Efficacy of Revanesse Shape + With Lidocaine Versus Juvederm Voluma With Lidocaine for the Correction of Age-Related Midface Volume Deficit / Lipoatrophy at 6 and 12 Months Post-treatment (Completed, started 2021-04-21)
- NCT04029519: A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation (Completed, started 2018-12-21)
- NCT04032977: Safety and Effectiveness of PN40082 for Lip Augmentation (Completed, started 2018-07-13)
- NCT02991040: Study to Evaluate Safety and Efficacy of Revanesse® Ultra + vs Revanesse® Ultra for Correction of NLF (Completed, started 2016-08)
- NCT02984878: Multicenter Study to Evaluate the Safety and Efficacy of Revanesse® Ultra Retreatment (Completed, started 2015-11)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Prollenium Medical Technologies, Inc. (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via LMH)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via LMH)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via LMH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Prollenium Medical Technologies, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Prollenium Medical Technologies, 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 Prollenium Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are LMH (Implant, Dermal, For Aesthetic Use, 1).
Next steps
- See all 0 Prollenium Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LMH, Prollenium Medical Technologies, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.