FDA.reportPublic FDA data

PINNACLE BIOLOGICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101191523010119152PINNACLE BIOLOGICS, INC.1N2026-01-012801 Lakeside Drive Suite 210 Bannockburn IL US 60015

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00376128000193Photofrin® 630 PDT Laser - 630 nm Photodynamic Therapy Laser1-847-283-7690info@pinnaclebiologics.com
00376128000223Optiguide® Cylindrical Fiber Optic Diffuser - 1.0cm rigid fiber optic diffuser for use in photodynamic therapy.8472837690productinfo@concordialaboratories.com
00376128000223Optiguide® Cylindrical Fiber Optic Diffuser - 1.0cm rigid fiber optic diffuser for use in photodynamic therapy.1-866-248-2039productinfo@concordialaboratories.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1566501389380802P990021DIOMED 630 PDT LASERMVF2000-06-30
1566501053869477P940010OPTIGUIDE(TM) FIBER OPTIC DIFFUSERMVG1995-12-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MVF12000-06-30
MVG11995-12-27

NDC#

Photofrin

Pinnacle Biologics, Inc.

Porfimer Sodium

PMA#

PHOTOFRIN 630 PDT Laser

2022-03-02

Pinnacle Biologics, Inc.2801 Lakeside Drive. Suite 210bannockburn, IL 60015 PMA NumberP990021 Supplement NumberS005 Date Received04/27/2021 Decision Date03/02/2022 Product Code MVF  Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day ...

GUDID#