REVANESSE ULTRA
FDA premarket approval P160042 · decided 2017-08-04
Approval details
- PMA number
- P160042
- Trade name
- REVANESSE ULTRA
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2016-09-22
- Decision date
- 2017-08-04
- Days to decision
- 316 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for the Revanesse Ultra. The device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults 22 years of age or more.
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