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PACEART OPTIMA™ System POS12D13

by Medtronic, Inc.

PACEART OPTIMA™ System POS12D13 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K110693 on 8 Jun 2011 and listed in FDA GUDID since 1 Apr 2016 (UDI-DI 00643169345058), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K110693

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 Number00643169345058 UDI-DI Date1 Apr 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK110693 Date8 Jun 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110693 decided 8 Jun 2011 Active
  • FDA GUDID UDI-DI 00643169345058 listed 1 Apr 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110693
  2. Listed FDA GUDID 00643169345058

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PACEART OPTIMA™ System
Generic name
Patient health record information system application software
Model / reference
POS12D13
Primary DI / UDI-DI
00643169345058
510(k) Number
FDA product code
DPS, KRE, DXH, OUG
GMDN term
Patient health record information system application software
Device class
Class II
Regulation number
870.2340, 870.3640, 870.2920, 880.6310
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K110693)

and 4 more cleared under K110693

Similar devices

Other devices filed under FDA product code DPS (ELECTROCARDIOGRAPH).

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)