This page includes the latest FDA filings for Promepla. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3006617533 |
| FEI Number | 3006617533 |
| Name | PROMEPLA |
| Owner & Operator | PROMEPLA |
| Contact Address | 9 AVENUE ALBERT II -- MONACO MC-NA 98000 MC |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 9 AVENUE PRINCE ALBERT II MONACO Not Applicable, 98000 MC |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Registration Number | 3010659128 |
| FEI Number | 3010659128 |
| Name | PROMEDTECH |
| Owner & Operator | PROMEPLA |
| Contact Address | 9 AVENUE ALBERT II -- MONACO MC-NA 98000 MC |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | ZI MGHIRA 2 Fouchena Tunis, 2082 TN |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Registration Number | 3011816507 |
| FEI Number | 3011816507 |
| Name | Chuck Philipp |
| Owner & Operator | PROMEPLA |
| Contact Address | 9 AVENUE ALBERT II -- MONACO MC-NA 98000 MC |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1623 Sundance Place Longmont, CO 80504 US |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Registration Number | 3016096097 |
| FEI Number | 3016096097 |
| Name | Chuck Philipp |
| Owner & Operator | PROMEPLA |
| Contact Address | 9 AVENUE ALBERT II -- MONACO MC-NA 98000 MC |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1623 Sundance Place Longmont, CO 80504 US |
| Establishment Type | Manufacture Medical Device |
| Registration Number | 3010332759 |
| FEI Number | 3010332759 |
| Name | Rocamed Inc. |
| Owner & Operator | PROMEPLA |
| Contact Address | 9 AVENUE ALBERT II -- MONACO MC-NA 98000 MC |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2010 Corporate Ridge. Suite 700 McLean, VA 22102 US |
Device Company | Device | Date |
|---|---|---|
| Promepla | LumaFlex Plus Double J stent, 2 open tips, Ch/Fr7/L.28cm, without wire ROJF5728ST228 | 2024-01-15 |
| Promepla | LumaFlex Plus Double J stent, 2 open tips, Ch/Fr7/L.26cm, without wire ROJF5726ST228 | 2024-01-15 |
| Promepla | LumaFlex Plus Double J stent, 2 open tips, Ch/Fr7/L.24cm, without wire ROJF5724ST228 | 2024-01-15 |
| Promepla | LumaFlex Plus Double J stent, 2 open tips, Ch/Fr7/L.22cm, without wire ROJF5722ST228 | 2024-01-15 |
| Promepla | LumaFlex Plus Double J stent, 2 open tips, Ch/Fr6/L.28cm, without wire ROJF5628ST228 | 2024-01-15 |
| Promepla | LumaFlex Plus Double J stent, 2 open tips, Ch/Fr6/L.26cm, without wire ROJF5626ST228 | 2024-01-15 |
| Promepla | LumaFlex Plus Double J stent, 2 open tips, Ch/Fr6/L.24cm, without wire ROJF5624ST228 | 2024-01-15 |
| Promepla | LumaFlex Plus Double J stent, 2 open tips, Ch/Fr6/L.22cm, without wire ROJF5622ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr8/L.30cm, without wire ROJS9830ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr8/L.28cm, without wire ROJS9828ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr8/L.26cm, without wire ROJS9826ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr8/L.24cm, without wire ROJS9824ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.30cm, without wire ROJS9730ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.28cm, without wire ROJS9728ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.26cm, without wire ROJS9726ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.24cm, without wire ROJS9724ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.30cm, without wire ROJS9630ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.28cm, without wire ROJS9628ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.24cm, without wire ROJS9624ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.30cm, without wire ROJS9530ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.28cm, without wire ROJS9528ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.26cm, without wire ROJS9526ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire ROJS9524ST228 | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire ROJS9522ST228 | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 8 Fr - Length 30cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 8 Fr - Length 28cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 8 Fr - Length 26cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 8 Fr - Length 24cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 7 Fr - Length 30cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 7 Fr - Length 28cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 7 Fr - Length 26cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 7 Fr - Length 24cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 6 Fr - Length 30cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 6 Fr - Length 28cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 6 Fr - Length 26cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 6 Fr - Length 24cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 4,8 Fr - Length 28cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 4,8 Fr - Length 26cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 4,8 Fr - Length 24cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 8 Fr - Length 30cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 8 Fr - Length 28cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 8 Fr - Length 26cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 8 Fr - Length 24cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 7 Fr - Length 30cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 7 Fr - Length 28cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 7 Fr - Length 26cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 7 Fr - Length 24cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 6 Fr - Length 30cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 6 Fr - Length 28cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 6 Fr - Length 26cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 6 Fr - Length 24cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 4,8 Fr - Length 30cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 4,8 Fr - Length 28cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 4,8 Fr - Length 26cm | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 4,8 Fr - Length 24cm | 2024-01-15 |
| Promepla | LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.26cm, without wire ROJS9626ST228 | 2024-01-15 |
| Promepla | RocaJJ Soft Stent - Ø 4,8 Fr - Length 30cm | 2024-01-15 |
| Promepla | Y-CLIC ADAPTER ROMYCLICST228 | 2024-01-15 |
| Promepla | MORPHEUS PUMP TUBE SET 7435 | 2022-11-10 |
| Promepla | X-Filter basket XF36150 | 2022-05-06 |
| Promepla | JFil® Ureteral Suture Stent JFCS160 | 2022-04-14 |
| Promepla | JFil® Ureteral Suture Stent JFCS80 | 2022-04-14 |
| Promepla | Tuohy Borst with Y Luer Lock RTBY | 2021-03-04 |
| Promepla | Tuohy Borst Simple RTBS | 2021-03-04 |
| Promepla | Tipless Basket TIPL1300 | 2021-03-04 |
| Promepla | Six Wire Basket SIXW1700 | 2021-03-04 |
| Promepla | Filter Basket FILT1800 | 2021-03-04 |
| Promepla | Mitt Basket MITB1900 | 2021-03-04 |
| Promepla | OlyPercX PCNL Basket RFPERKX | 2020-09-04 |
| Promepla | RocaFlow Endoscopy Tubing RF2ENDO | 2020-09-04 |
| Promepla | Tubing, sterile, for UHl smoke evacuation ONG04299ST119 | 2020-07-07 |
| Promepla | Tubing, with filter, sterile, for insuflation ONG04199ST119 | 2020-07-07 |
| Promepla | Pure Graft Fat Lock System | 2020-05-14 |
| Promepla | OlyCath Straight 0 Eye 8 French OLCAS08 | 2020-05-14 |
| Promepla | OlyCath Straight 0 Eye 7 French OLCAS207 | 2020-05-14 |
| Promepla | OlyCath Straight 0 Eye 6 French OLCAS06 | 2020-05-14 |
| Promepla | OlyCath Straight 0 Eye 5 French OLCAS05 | 2020-05-14 |
| Promepla | OlyCath Straight 0 Eye 4 French OLCAS04 | 2020-05-14 |
| Promepla | OlyCath Curved 0 Eye 8 French OLCAC08 | 2020-05-14 |
| Promepla | OlyCath Curved 0 Eye 7 French OLCAC07 | 2020-05-14 |
| Promepla | OlyCath Curved 0 Eye 6 French OLCAC06 | 2020-05-14 |
| Promepla | OlyCath Curved 0 Eye 5 French OLCAC05 | 2020-05-14 |
| Promepla | OlyCath Curved 0 Eye 4 French OLCAC04 | 2020-05-14 |
| Promepla | OlyCath Straight 2 Eye 7 French OLCAS27 | 2020-05-14 |
| Promepla | OlyCath Straight 2 Eye 6 French OLCAS26 | 2020-05-14 |
| Promepla | OlyCath Straight 2 Eye 5 French OLCAS25 | 2020-05-14 |
| Promepla | OlyCath Straight 2 Eye 4 French OLCAS24 | 2020-05-14 |
| Promepla | Nitinol Stone Extractor, TIPLESS basket 4 wires, 2.2 Fr ROSZ2200ST | 2020-05-06 |
| Promepla | Nitinol Stone Extractor,TIPLESS basket 4 wires,1.9Fr Mini ROSZ1940ST | 2020-05-06 |
| Promepla | Nitinol Stone Extractor, TIPLESS basket 4 wires, 1.9 Fr Mini 'Criterium Handle' ROSZ1930ST | 2020-05-06 |
| Promepla | Nitinol Stone Extractor, TIPLESS basket 4 wires, 1.9 Fr Mini ROSZ1920ST | 2020-05-06 |
| Promepla | Nitinol Stone Extractor, TIPLESS basket 4 wires, 1.9 Fr ROSZ1900ST | 2020-05-06 |
| Promepla | Nitinol Stone Extractor, TIPLESS basket 4 wires, 1.3 Fr ROSZ1300ST | 2020-05-06 |
| Promepla | Nitinol Stone Extractor, helical basket, 4 wires, 2.5 Fr ROSH2500ST | 2020-05-06 |
| Promepla | Nitinol Stone Extractor, straight basket, 4 wires, 2.5 Fr ROSS2500ST | 2020-05-06 |
| Promepla | XenX™ – Stone Management Device (12cm tip length Mid Distal Stone) XE010112T | 2020-05-06 |
| Promepla | XenX™ – Stone Management Device (7cm tip length Proximal Stone) XE01017T | 2020-05-06 |
| Promepla | XenX – Stone Management Device (12cm tip length Mid Distal Stone) ROXE03812ST | 2020-05-06 |
| Promepla | XenX – Stone Management Device (7 cm tip Proximal Stone) ROXE03807ST | 2020-05-06 |
| Promepla | Extension line doble Luer Lock 1.7x3.0x23mm ODG0015USST | 2020-04-13 |
PROMEDTECH [PROMEPLA] | Irrigation/Aspiration set | 2018-05-10 |
Chuck Philipp [PROMEPLA] | Irrigation/Aspiration set | 2018-05-10 |
PROMEDTECH [PROMEPLA] | RocaJJ Soft Stents | 2018-04-30 |
Chuck Philipp [PROMEPLA] | RocaJJ Soft Stents | 2018-04-30 |
PROMEPLA | Tubing set disposable | 2016-11-04 |
Chuck Philipp [PROMEPLA] | Tubing set disposable | 2016-11-04 |
Chuck Philipp [PROMEPLA] | Tubing set disposable | 2016-11-04 |
Chuck Philipp [PROMEPLA] | Extension line double female luer lock diam 1.7 x 3.0 x 23mm | 2016-07-06 |
Chuck Philipp [PROMEPLA] | Extension line double female luer lock diam 1.7 x 3.0 x 23mm | 2016-07-06 |
PROMEDTECH [PROMEPLA] | RocaFlow - Irrigation, Warming and Suction System | 2016-02-11 |
PROMEDTECH [PROMEPLA] | ENDOFLOW II - Irrigation, Warming and Suction System | 2016-02-11 |
Chuck Philipp [PROMEPLA] | RocaFlow - Irrigation, Warming and Suction System | 2016-02-11 |
Chuck Philipp [PROMEPLA] | RocaFlow - Irrigation, Warming and Suction System | 2016-02-11 |
Chuck Philipp [PROMEPLA] | ENDOFLOW II - Irrigation, Warming and Suction System | 2016-02-11 |
Chuck Philipp [PROMEPLA] | ENDOFLOW II - Irrigation, Warming and Suction System | 2016-02-11 |
PROMEDTECH [PROMEPLA] | Ureteral Access Sheath | 2016-02-11 |
Chuck Philipp [PROMEPLA] | Ureteral Access Sheath | 2016-02-11 |
PROMEDTECH [PROMEPLA] | Irrigation lines | 2013-01-17 |
PROMEDTECH [PROMEPLA] | Irrigation line KM | 2013-01-17 |
PROMEDTECH [PROMEPLA] | Irrigation Tube | 2013-01-17 |
PROMEDTECH [PROMEPLA] | Irrigation Chiropro L3.5m | 2013-01-17 |
PROMEDTECH [PROMEPLA] | Endoscopic irrigation line TraxerFlow, double spikes, with flushing pump, universal connector and Tuohy-Borst | 2013-01-17 |
PROMEDTECH [PROMEPLA] | Catheter for irrigation, irrigation line | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Irrigation lines | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Irrigation lines | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Irrigation line KM | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Irrigation line KM | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Irrigation Tube | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Irrigation Tube | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Irrigation Chiropro L3.5m | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Irrigation Chiropro L3.5m | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Endoscopic irrigation line TraxerFlow, double spikes, with flushing pump, universal connector and Tuohy-Borst | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Endoscopic irrigation line TraxerFlow, double spikes, with flushing pump, universal connector and Tuohy-Borst | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Catheter for irrigation, irrigation line | 2013-01-17 |
Chuck Philipp [PROMEPLA] | Catheter for irrigation, irrigation line | 2013-01-17 |
PROMEPLA | DEVICE, CYSTOMETRIC, HYDRAULIC | 2012-09-24 |
PROMEDTECH [PROMEPLA] | Tubing, sterile, for UIII smoke evaluation | 2011-01-25 |
Chuck Philipp [PROMEPLA] | Tubing, sterile, for UIII smoke evaluation | 2011-01-25 |
PROMEDTECH [PROMEPLA] | ROCAMED RocaStone Stone Extractors | 2010-12-15 |
Chuck Philipp [PROMEPLA] | ROCAMED RocaStone Stone Extractors | 2010-12-15 |
PROMEDTECH [PROMEPLA] | Rocamed RocaWire Guidewires; Roca Wire Rio Tracer | 2010-12-15 |
Chuck Philipp [PROMEPLA] | Rocamed RocaWire Guidewires; Roca Wire Rio Tracer | 2010-12-15 |
PROMEPLA | PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET | 2007-10-04 |
PROMEDTECH [PROMEPLA] | Tubing, with filter, sterile, for insufflation | 2007-08-01 |
Chuck Philipp [PROMEPLA] | Tubing, with filter, sterile, for insufflation | 2007-08-01 |