PMA P240008

Device
saypha® MagIQ™
Applicant
Croma-Pharma GmbH
PMA number
P240008
Product code
LMH
Decision date
2025-09-08
Classification
General, Plastic Surgery
Generic name
Implant, dermal, for aesthetic use
Approval order 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.

Current openFDA PMA Record

Device
saypha® MagIQ™
Applicant
Croma-Pharma GmbH
PMA number
P240008
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2025-09-08
Decision code
APPR
Date received
2024-03-27
Approval order 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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