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PMA P940010S004

Device
OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
Applicant
Pinnacle Biologics, Inc.
PMA number
P940010
Supplement
S004
Product code
MVG
Decision date
1998-12-23
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(TM) FIBER OPTIC DIFFUSER
Applicant
Pinnacle Biologics, Inc.
PMA number
P940010
Supplement
S004
Product code
MVG
Generic name
System, laser, fiber optic, photodynamic therapy
Decision date
1998-12-23
Decision code
APPR
Date received
1998-03-24
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).