Restylane Refyne, Restylane Defyne
FDA premarket approval P140029 · decided 2016-12-09
Approval details
- PMA number
- P140029
- Trade name
- Restylane Refyne, Restylane Defyne
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2014-12-11
- Decision date
- 2016-12-09
- Days to decision
- 729 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for Restylane Refyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21. Restylane Defyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe, deep facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.