ENTERYX PROCEDURE KIT
FDA premarket approval P020006 · decided 2003-04-22
Approval details
- PMA number
- P020006
- Trade name
- ENTERYX PROCEDURE KIT
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Boston Scientific Corp
- Date received
- 2002-02-11
- Decision date
- 2003-04-22
- Days to decision
- 435 days
- Decision code
- APWD
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- APPROVAL FOR THE ENTERYX PROCEDURE KIT. THE DEVICE IS INDICATED FOR ENDOSCOPIC INJECTION INTO THE REGION OF THE LOWER ESOPHAGEAL SPHINCTER (LES) FOR THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD) SYMPTOMS IN PATIENTS RESPONDING TO AND REQUIRING DAILY PHARMACOLOGICAL THERAPY WITH PROTON PUMP INHIBITORS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245) | Boston Scientific Corp | 2024-10-18 |
| LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328) | Boston Scientific Corp | 2023-08-19 |
| WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853) | Boston Scientific Corp | 2015-11-20 |
| AXIOS Stent with Electrocautery Enhanced Delivery System (K150692) | Boston Scientific Corp | 2015-08-05 |
| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
| Chariot Guiding Sheath (K150186) | Boston Scientific Corp | 2015-06-05 |
| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |