Accolade™ El Dr L321

by Boston Scientific

Accolade™ El Dr L321 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 11 Nov 2014 (UDI-DI 00802526559242), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00802526559242 UDI-DI	Date11 Nov 2014Listed	StatusListed GUDID: in commercial distribution
United States	FDA PMAAPPR from GUDID Approved	NumberN970003	Date12 Mar 2013Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00802526559242

Across registries

2 registries list this device

FDA premarket submission N970003 decided 12 Mar 2013 Active
FDA GUDID UDI-DI 00802526559242 listed 11 Nov 2014 Listed

Timeline

2 dated events

12 Mar 2013 Decided FDA premarket submission N970003
11 Nov 2014 Listed FDA GUDID 00802526559242

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name: Accolade™ El Dr
Generic name: Dual-chamber implantable pacemaker, rate-responsive
Model / Ref / Catalog: L321

Primary DI / UDI-DI: 00802526559242
FDA product code: LWP
GMDN term: Dual-chamber implantable pacemaker, rate-responsive

Device class: Class III
GUDID distribution status: In Commercial Distribution

Other devices from Boston Scientific

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Serial number
Expiration date

Other properties (9, all answered No)