The following data is part of a De Novo classification by Gelesis, Inc. with the FDA for Plenity.
DeNovo ID | DEN180060 |
Device Name: | Plenity |
Classification | Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss |
Applicant | Gelesis, Inc. 501 Boylston Street, Suite 6102 Boston, MA 02116 |
Contact | Eyal Ron |
Product Code | QFQ |
CFR Regulation Number | 876.5982 [🔎] |
Decision | Granted (DENG) |
Review Advisory Board | Gastroenterology/Urology |
Classification Advisory | Gastroenterology/Urology |
Type | Direct |
Date Received | 2018-11-15 |
Decision Date | 2019-04-12 |
Reclassification Order: | Reclassification Order |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860517002627 | DEN180060 | 000 |
00860517002634 | DEN180060 | 000 |