# Sorin CRM SAS · 89-08 · FRANCE — FDA import alert red lists: firms subject to detention without physical examination

For Sorin CRM SAS · 89-08 · FRANCE, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is FRANCE; product code is 74 D - - RO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive); date published is 09/16/2009; address is Cvk , Acmo Parc; 10 Avenue Reaumur , Clamart Cedex, Hauts de Seine FRANCE, verified against its source on 2026-09-16.

- **Firm:** Sorin CRM SAS _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** FRANCE _(verified: appears in the quote below)_
- **Address:** Cvk , Acmo Parc; 10 Avenue Reaumur , Clamart Cedex, Hauts de Seine FRANCE _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 74 D - - RO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) _(verified: appears in the quote below)_
- **FDA notes:** 9/9/1992 Chorus RM cardia pacemaker model 7023. Chorus II cardia pacemaker model 6234 _(verified: appears in the quote below)_

## What the source says

> Sorin CRM SAS Date Published : 09/16/2009 Cvk , Acmo Parc; 10 Avenue Reaumur , Clamart Cedex, Hauts de Seine FRANCE 74 D - - RO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) Date Published: 09/16/2009 Notes: 9/9/1992 Chorus RM cardia pacemaker model 7023. Chorus II cardia pacemaker model 6234

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).