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D2-Kit 75

by BIOTRONIK SE & Co. KG

D2-Kit 75 (384135) 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 19 Aug 2014 (UDI-DI 04035479143466), 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 found

in data synced 23 Oct 2026

Documents

PMA P980023

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 Number04035479143466 UDI-DI Date19 Aug 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP980023 Date27 Oct 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P980023 decided 27 Oct 1998 Active
  • FDA GUDID UDI-DI 04035479143466 listed 19 Aug 2014 Listed

Timeline

2 dated events

  1. Approved FDA PMA P980023
  2. Listed FDA GUDID 04035479143466

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
D2-Kit
Generic name
Endocardial defibrillation lead
Model / Ref / Catalog
75, 384135
Primary DI / UDI-DI
04035479143466
PMA number
FDA product code
NVY
GMDN term
Endocardial defibrillation lead
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endocardial defibrillation lead

Cleared under the same submission (P980023)

and 8 more cleared under P980023

Other devices from BIOTRONIK SE & Co. KG

See all devices from BIOTRONIK SE & Co. KG →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)