Sorin CRM SAS · 89-08 · FRANCE
For Sorin CRM SAS, import alert is 89-08; country is FRANCE; 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)"; 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 2026-09-30.
- Firm
- Sorin CRM SAS verified
- 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
- Address
- Cvk , Acmo Parc; 10 Avenue Reaumur , Clamart Cedex, Hauts de Seine FRANCE verified
- Date published
- 09/16/2009 verified
- Product code
- 74 D - - RO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) verified
- FDA notes
- 9/9/1992 Chorus RM cardia pacemaker model 7023. Chorus II cardia pacemaker model 6234 verified
What the source says
Sorin CRM SAS Date Published : 09/16/2009 Cvk , Acmo Parc; 10 Avenue Reaumur , Clamart Cedex, Hauts de Seine FRANCE
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.