The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the advisory on the following medical device products under FDA Advisory No. 2020-1811 dated 05 October 2020 is hereby lifted pursuant to the compliance of the Market Authorization Holder (MAH) Boston Scientific Philippines, Inc. in accordance to existing FDA rules and regulations.
1. PolarisTM Loop – Dual Durometer PercuflexTM Material – Ureteral Stent (Product No. M0061552440)
2. Contour VLTM – Soft PercuflexTM Material – Variable Length Ureteral Stent (Product No. M0061801570)
The provisions of FDA Advisory No. 2020-1811 indicating unregistered medical device product is still in effect.
The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected] or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of unregistered medical device, contact the online reporting facility, eReport, through e-mail at [email protected].
Dissemination of this advisory to all concerned is hereby requested.