| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9710154 | 3003347293 | Q-MED AB | 1 | N | 2026-01-01 | SEMINARIEGATAN 21 UPPSALA SE SE-752 28 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 19301 | 1858934044 | P140029 | Restylane Refyne, Restylane Defyne | LMH | 2016-12-09 |
| 19301 | 1623625533 | P040024 | RESTYLANE INJECTABLE GEL | LMH | 2005-03-25 |
| 19301 | 1072980785 | P030050 | SCULPTRA AND SCULPTRA AESTHETIC | LMH | 2004-08-03 |
| 19301 | 1374294527 | ||||
| 19301 | 1433800339 | ||||
| 19301 | 2005472140 | ||||
| 19301 | 2060557447 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LMH | 3 | 2016-12-09 |
Q-Med ABseminariegatan 21uppsala S-752-7522 PMA NumberP140029 Supplement NumberS047 Date Received11/21/2022 Decision Date12/23/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Typespecial (immediate Track) Supplement Reason Lab...
Q-Med ABseminariegatan 21uppsala SE-75-752- PMA NumberP040024 Supplement NumberS136 Date Received11/21/2022 Decision Date12/23/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Typespecial (immediate Track) Supplement Reason Lab...
Q-Med ABseminariegatan 21uppsala S-752-7522 PMA NumberP140029 Supplement NumberS046 Date Received09/07/2022 Decision Date10/04/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change ...
Q-Med ABseminariegatan 21uppsala SE-75-752- PMA NumberP040024 Supplement NumberS134 Date Received09/07/2022 Decision Date09/30/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change ...
Q-Med ABseminariegatan 21uppsala SE-75-752- PMA NumberP040024 Supplement NumberS131 Date Received04/04/2022 Decision Date07/20/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplement Reason Change Desi...
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