saypha® MagIQ
FDA premarket approval P240008 · decided 2025-09-08
Approval details
- PMA number
- P240008
- Trade name
- saypha® MagIQ
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Croma-Pharma GmbH
- Date received
- 2024-03-27
- Decision date
- 2025-09-08
- Days to decision
- 530 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Leobendorf
- Statement
- Approval for saypha® MagIQ for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
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