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BlueSky TPM021U

by Microport Crm SRL

BlueSky TPM021U 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 08031527019000), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P950029

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08031527019000 UDI-DI Date23 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP950029 Date10 Mar 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P950029 decided 10 Mar 1997 Active
  • FDA GUDID UDI-DI 08031527019000 listed 23 Jun 2023 Listed

Recalls

1 recall · FDA

    • Terminated Z-2235-2009 FDA Unclassified (pre-2012) initiated 23 Sep 2008 on shared PMA P950029

    Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Approved FDA PMA P950029
  2. Recall initiated FDA recalls Z-2235-2009
  3. Listed FDA GUDID 08031527019000

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
BlueSky
Generic name
Single-chamber implantable pacemaker, rate-responsive
Model / Ref / Catalog
TPM021U
Primary DI / UDI-DI
08031527019000
PMA number
FDA product code
DXY
GMDN term
Single-chamber implantable pacemaker, rate-responsive
Device class
Class III
Regulation number
870.3610
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Single-chamber implantable pacemaker, rate-responsive

Cleared under the same submission (P950029)

and 8 more cleared under P950029

Similar devices

Other devices filed under FDA product code DXY (Implantable Pacemaker Pulse-Generator).

Other devices from Microport Crm SRL

See all devices from Microport Crm SRL →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)