Plexa ProMRI DF-1 S DX 65/15
Plexa ProMRI DF-1 S DX 65/15 (414005) is a Class III device made by BIOTRONIK SE & Co. KG, approved under FDA PMA P980023 on 27 Oct 1998 and listed in FDA GUDID since 27 Mar 2017 (UDI-DI 04035479151027), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04035479151027 | Date27 Mar 2017 | StatusListed |
| United States | FDA PMAAPPR | NumberP980023 | Date27 Oct 1998 | StatusActive |
Official records
- AccessGUDID record 04035479151027
- FDA PMA database P980023
Across registries
- FDA PMA P980023 decided 27 Oct 1998 Active
- FDA GUDID UDI-DI 04035479151027 listed 27 Mar 2017 Listed
Timeline
- Approved FDA PMA P980023
- Listed FDA GUDID 04035479151027
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Plexa ProMRI
- Generic name
- Endocardial defibrillation lead
- Model / Ref / Catalog
- DF-1 S DX 65/15, 414005
- Primary DI / UDI-DI
- 04035479151027
- PMA number
- FDA product code
- NVY
- GMDN term
- Endocardial defibrillation lead
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional