Data / Medical devices / United States / Pinnacle Biologics, Inc.
Pinnacle Biologics, Inc.: FDA-registered device maker in Bannockburn, IL, United States, 2 PMA approvals
Pinnacle Biologics, Inc. is registered with the FDA (registration 3010119152) in Bannockburn, IL, United States. It lists 2 device types. The FDA files 2 PMA approvals under its listings, the newest dated June 30, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010119152
- Address
- 2801 Lakeside Drive Suite 210, Bannockburn, IL, United States, 60015
- Owner or operator
- Advanz Pharma (US) Corp. (10043852)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 28, 2013
- Registered through
- 2026
- Brand names listed
- ANGIO DYNAMICS 630PDT LASER, DIOMED 630 PDT LASER, OPTIGUIDE FIBER OPTIC DIFFUSER, PHOTOFRIN 630 PDT LASER; MODEL 63012
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Laser, Fiber Optic, Photodynamic Therapy | MVG | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Laser, Photodynamic Therapy | MVF | 3 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 30, 2000 | P990021 | DIOMED 630 PDT LASER | MVF | 5 | March 2, 2022 | accessdata.fda.gov |
| December 27, 1995 | P940010 | OPTIGUIDE(TM) FIBER OPTIC DIFFUSER | MVG | 17 | February 24, 2021 | accessdata.fda.gov |
Compare with other makers
Updated March 2, 2022. 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.