Replies to post #23268 on SpectraScience Inc (SCIE)

[GtSharks]

I looked into that number and the only information on it is from 2000:

I can't find any information indicating anything new has happened. This is a 17 year old approval. If anyone can show new information, new approval, new anything I would love to see it. Having said that, The price action and vol suggests something is most definitely up... I suspect just a P&D which is fine by me...



Device OPTICAL BIOPSY(TM) SYSTEM
Classification Name Analyzer, Diagnostic, Fiber Optic (Colon)
Generic Name Analyzer, Diagnostic, Fiber Optic (Colon)
Applicant
SPECTRA SCIENCE
11568 Sorrento Valley Rd,Suite
11
San Diego, CA 92121

PMA Number P990050
Date Received 08/24/1999
Decision Date 11/14/2000
Product Code
MOA [ Registered Establishments With MOA ]
Docket Number 01M-0478
Notice Date 10/19/2001
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product
No

Approval Order Statement

APPROVAL FOR THE OPTICAL BIOPSY(TM) SYSTEM. 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).

[retireat40]

1 to 8 of 8 Results PMA Number: P990050 Decision Date to 10/04/2017 ... Number. Sort by PMA Number [0-9] 12. Sort by PMA Number [9-0] 13. Decision Date.
Premarket Approval (PMA) - FDA

[PENNIEStoSTACKS]

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990050