PMA P990021S001

Device: DIOMED 630 PDT LASER
Applicant: Pinnacle Biologics, Inc.
PMA number: P990021
Supplement: S001
Product code: MVF
Decision date: 2003-08-01
Classification: System, Laser, Photodynamic Therapy
Generic name: System, laser, photodynamic therapy
Approval order statement: APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE ADDITIONAL INDICATION FOR USE FOR THE ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY.

Current openFDA PMA Record#

Device: DIOMED 630 PDT LASER
Applicant: Pinnacle Biologics, Inc.
PMA number: P990021
Supplement: S001
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2003-08-01
Decision code: APPR
Date received: 2002-06-12
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE ADDITIONAL INDICATION FOR USE FOR THE ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY.