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Advantio™ K063

by Boston Scientific

Advantio™ K063 is a Class III device made by Boston Scientific, listed under FDA premarket submission N970003 on 12 Mar 2013 and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 00802526516702), active as of 22 Oct 2026.

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA N970003

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00802526516702 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberN970003 Date12 Mar 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission N970003 decided 12 Mar 2013 Active
  • FDA GUDID UDI-DI 00802526516702 listed 24 Sep 2014 Listed

Timeline

2 dated events

  1. Decided FDA premarket submission N970003
  2. Listed FDA GUDID 00802526516702

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Advantio™
Generic name
Dual-chamber implantable pacemaker, rate-responsive
Model / reference
K063
Primary DI / UDI-DI
00802526516702
FDA product code
LWP
GMDN term
Dual-chamber implantable pacemaker, rate-responsive
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dual-chamber implantable pacemaker, rate-responsive

Cleared under the same submission (N970003)

and 8 more cleared under N970003

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (9, all answered No)