BlueSky TPM020U
BlueSky TPM020U is a Class III device made by Microport Crm SRL, approved under FDA PMA P950029 on 10 Mar 1997 and listed in FDA GUDID since 23 Jun 2023 (UDI-DI 08031527018997), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08031527018997 | Date23 Jun 2023 | StatusListed |
| United States | FDA PMAAPPR | NumberP950029 | Date10 Mar 1997 | StatusActive |
Official records
- AccessGUDID record 08031527018997
- FDA PMA database P950029
Across registries
- FDA PMA P950029 decided 10 Mar 1997 Active
- FDA GUDID UDI-DI 08031527018997 listed 23 Jun 2023 Listed
Recalls
-
- Terminated Z-2235-2009
Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew.
Timeline
- Approved FDA PMA P950029
- Recall initiated FDA recalls Z-2235-2009
- Listed FDA GUDID 08031527018997
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- BlueSky
- Generic name
- Dual-chamber implantable pacemaker, rate-responsive
- Model / Ref / Catalog
- TPM020U
- Primary DI / UDI-DI
- 08031527018997
- PMA number
- FDA product code
- DXY
- GMDN term
- Dual-chamber implantable pacemaker, rate-responsive
- Device class
- Class III
- Regulation number
- 870.3610
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices
Other devices filed under FDA product code DXY (Implantable Pacemaker Pulse-Generator).
- Unifocal 2-UNIPOLAR & Bipolar by American Pacemaker Corp.
- Stilith Cardiac Pacemakers-M 60 & 120 by R.E. Brown Co., Inc.
- Cardiac Pulse Generator 250B by Telectronics, Inc.
- Unilith Pulse Generator by Ela Medical, Inc.
- Opus Models 4033 and 4034 Implantable Pacemaker Pulse-Generator by Ela Medical, Inc.
- Implantable Pulse Generator Pacemakers by Intermedics, Inc.
- MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE by Pace Medical
- Pacemaker Model 251 by Intermedics, Inc.
- NOMOS-01 Pulse Generator by Biotronik Sales, Inc.
- Command Ultra II by Cardiac Pacemakers, Inc.