PMA P250021S002

Device: saypha® ChiQ™
Applicant: Croma-Pharma GmbH
PMA number: P250021
Supplement: S002
Product code: LMH
Decision date: 2026-10-08
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250021.

Current openFDA PMA Record#

Device: saypha® ChiQ™
Applicant: Croma-Pharma GmbH
PMA number: P250021
Supplement: S002
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-10-08
Decision code: APPR
Date received: 2026-07-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250021.