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PMA P940010S007

Device
OPTIGUIDE CYLINDRICAL FIBER OPTIC
Applicant
Pinnacle Biologics, Inc.
PMA number
P940010
Supplement
S007
Product code
MVG
Decision date
1999-08-13
Classification
System, Laser, Fiber Optic, Photodynamic Therapy
Generic name
System, laser, fiber optic, photodynamic therapy
Approval order statement
Approval for revision ot the package labeling and package insert labeling. The approved modifications include clarification of directions for use and device descriptions and simplification of use of trademark or registered trademark symbols.

Current openFDA PMA Record#

Device
OPTIGUIDE CYLINDRICAL FIBER OPTIC
Applicant
Pinnacle Biologics, Inc.
PMA number
P940010
Supplement
S007
Product code
MVG
Generic name
System, laser, fiber optic, photodynamic therapy
Decision date
1999-08-13
Decision code
APPR
Date received
1999-07-08
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revision ot the package labeling and package insert labeling. The approved modifications include clarification of directions for use and device descriptions and simplification of use of trademark or registered trademark symbols.