SCULPTRA® (injectable poly-L Lactic acid)
Q-Med AB · Implant, dermal, for aesthetic use · General, Plastic Surgery
Open FDA's page for this record- PMA number
- P030050
- Supplement number
- S056
- Applicant
- Q-Med AB
- Street 1
- Seminariegatan 21
- City
- Uppsala
- Zip
- SE-752-28
- Generic name
- Implant, dermal, for aesthetic use
- Trade name
- SCULPTRA® (injectable poly-L Lactic acid)
- Product code
- LMH
- Advisory committee
- SU
- Advisory committee description
- General, Plastic Surgery
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-08-19
- Decision date
- 2026-09-17
- Decision code
- OK30
- Ao statement
- Approval to modify compounding reactors R11 and R12 to be consistent with reactor systems R11A and R12A.
- Harmonized identifiers (openFDA)
- Device name
- Implant, Dermal, For Aesthetic Use
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3003672980, 3036164410, 2011068, 3022121566, 3007772056, 3031983053, 3005113652, 3019585045, 3009882464, 3015471896, 1000118068, 3003707320, 3007093114, 3004362706, 3013840437, 3045078914, 3043045982, 3002806738, 3033486016, 3010164402, 3043624366, 3026391021, 3031056804, 3006999111, 3015373820, 3004423487, 3042708459, 3006123332, 3027345797, 9710154, 3005975625, 2135225, 3037006441, 3048051492, 3002807108, 3007744205
- FEI number
- 3003672980, 3036164410, 2011068, 3022121566, 3007772056, 3003347293, 3031983053, 3005113652, 3019585045, 3009882464, 3015471896, 1000118068, 3003707320, 3007093114, 3004362706, 3013840437, 3045078914, 3043045982, 3002806738, 3033486016, 3043624366, 3026391021, 3007517952, 3006999111, 3031056804, 3015373820, 3004423487, 3042708459, 3006123332, 3027345797, 3005975625, 3037006441, 3003407669, 3048051492, 3002807108, 3007744205