PMA P030050S038
- Device
- SCULPTRA
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S038
- Product code
- LMH
- Decision date
- 2022-01-21
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- SCULPTRA
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S038
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-01-21
- Decision code
- APPR
- Date received
- 2021-12-22
- 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) protocol.