Reference Source

Sorin CRM SAS · 89-08 · FRANCE

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

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