PMA P990050S002

Device: WAVSTAT OPTICAL BIOPSY SYTEM
Applicant: Spectra Science
PMA number: P990050
Supplement: S002
Product code: MOA
Decision date: 2001-08-17
Classification: Analyzer, Diagnostic, Fiber Optic (colon)
Generic name: ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
Approval order statement: APPROVAL FOR A CHANGE IN THE TRADE NAME OF THE DEVICE AND RELATED ACCESSORIES TO ADD THE WORD "WAVSTAT(TM)" TO THE BEGINNING OF THE TRADE NAME. THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO LOWER GASTROINTESTINAL (GI) ENDOSCOPY. THE DEVICE IS INTENDED FOR THE EVALUATION OF POLYPS LESS THAN 1 CM IN DIAMETER THAT THE PHYSICIAN HAS NOT ALREADY ELECTED TO REMOVE. THE DEVICE IS ONLY TO BE USED IN DECIDING WHETHER SUCH POLYPS SHOULD BE REMOVED (WHICH INCLUDES SUBMISSION FOR HISTOLOGICAL EXAMINATION).

Current openFDA PMA Record

Device: WAVSTAT OPTICAL BIOPSY SYTEM
Applicant: Spectra Science
PMA number: P990050
Supplement: S002
Product code: MOA
Generic name: ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
Decision date: 2001-08-17
Decision code: APPR
Date received: 2001-07-20
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A CHANGE IN THE TRADE NAME OF THE DEVICE AND RELATED ACCESSORIES TO ADD THE WORD "WAVSTAT(TM)" TO THE BEGINNING OF THE TRADE NAME. THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO LOWER GASTROINTESTINAL (GI) ENDOSCOPY. THE DEVICE IS INTENDED FOR THE EVALUATION OF POLYPS LESS THAN 1 CM IN DIAMETER THAT THE PHYSICIAN HAS NOT ALREADY ELECTED TO REMOVE. THE DEVICE IS ONLY TO BE USED IN DECIDING WHETHER SUCH POLYPS SHOULD BE REMOVED (WHICH INCLUDES SUBMISSION FOR HISTOLOGICAL EXAMINATION).