Reference Source

Promotus S A · 89-08 · SWITZERLAND

For Promotus S A · 89-08 · SWITZERLAND, 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 SWITZERLAND; product is Implantable Device | Implantable Device | Implantable Device; product code is 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 87 - - - -- Orthopedic; date published is 06/20/2019; address is Route De Divonne 48 , Nyon, Vaud SWITZERLAND, verified against its source on 2026-09-16.

Firm
Promotus S A 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
SWITZERLAND verified
Address
Route De Divonne 48 , Nyon, Vaud SWITZERLAND verified
Date published
06/20/2019 verified
Product code
76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 87 - - - -- Orthopedic each item verified
Product
Implantable Device | Implantable Device | Implantable Device each item verified
FDA notes
DWPE Date; 4/23/1992 | DWPE Date; 4/23/1992 | DWPE Date; 4/23/1992 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Promotus S A Date Published : 06/20/2019 Route De Divonne 48 , Nyon, Vaud SWITZERLAND 76 - - - -- Dental Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992 77 - - - -- Ear,Nose And Throat Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992 87 - - - -- Orthopedic Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992

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

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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