PMA P950042S001

Device: XILLIX-LIFE-LUNG
Applicant: Novadaq Technologies, Inc.
PMA number: P950042
Supplement: S001
Product code: MRK
Decision date: 1998-07-21
Generic name: SYSTEM, IMAGING, FLUORESCENCE
Approval order statement: Approval to amend the post-market study. A third investigator will be added to assist in collecting sets of images whichwill be used to produce the "test set" of images for the reproducibility testing.

Current openFDA PMA Record#

Device: XILLIX-LIFE-LUNG
Applicant: Novadaq Technologies, Inc.
PMA number: P950042
Supplement: S001
Product code: MRK
Generic name: SYSTEM, IMAGING, FLUORESCENCE
Decision date: 1998-07-21
Decision code: APPR
Date received: 1998-04-30
Supplement type: Normal 180 Day Track
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval to amend the post-market study. A third investigator will be added to assist in collecting sets of images whichwill be used to produce the "test set" of images for the reproducibility testing.