PMA P940010S006

Device: OPTIGUIDE CYLINDRICAL FIBER OPTIC(DCYL2 DIFFUSER SERIES)
Applicant: Pinnacle Biologics, Inc.
PMA number: P940010
Supplement: S006
Product code: MVG
Decision date: 1999-03-04
Classification: System, Laser, Fiber Optic, Photodynamic Therapy
Generic name: System, laser, fiber optic, photodynamic therapy
Approval order statement: Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).

Current openFDA PMA Record#

Device: OPTIGUIDE CYLINDRICAL FIBER OPTIC(DCYL2 DIFFUSER SERIES)
Applicant: Pinnacle Biologics, Inc.
PMA number: P940010
Supplement: S006
Product code: MVG
Generic name: System, laser, fiber optic, photodynamic therapy
Decision date: 1999-03-04
Decision code: APPR
Date received: 1999-02-08
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).