PMA P250016S004

Device: Belotero® Intense (+) Lidocaine
Applicant: Merz North America, Inc.
PMA number: P250016
Supplement: S004
Product code: LMH
Decision date: 2026-08-31
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 P250016.

Current openFDA PMA Record#

Device: Belotero® Intense (+) Lidocaine
Applicant: Merz North America, Inc.
PMA number: P250016
Supplement: S004
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-08-31
Decision code: APPR
Date received: 2026-08-04
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 P250016.