Revanesse® Lips+
FDA premarket approval P160042/S010 · decided 2020-09-21
Approval details
- PMA number
- P160042
- Supplement
- S010
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Revanesse® Lips+
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2019-09-30
- Decision date
- 2020-09-21
- Days to decision
- 357 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- Approval for the Revanesse® Lips+. The device is indicated for submucosal implantation for lip augmentation in patients 22 years of age or older.
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