Medical device licence · 12484 · Class 4
PROLENE POLYPROPYLENE SUTURE
Yes: licensed in Canada
Licence status Issued (active); first licensed September 23, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 12484
- Licence holder
- Ethicon Inc.Neuchatel 2000, NE, Switzerland
- Risk class
- Class IV (highest risk)
- Licence type
- Device Group Family
- First licensed
- September 23, 1999
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROLENE SUTURE - PRECISION COSMETIC CONVENTIONAL CUTTING PRIME
- PROLENE SUTURE - PRECISION POINT REVERSE CUTTING
- PROLENE SUTURE - REVERSE CUTTING
- PROLENE SUTURE - STRAIGHT
- PROLENE SUTURE - TAPER CUT
- PROLENE SUTURE - TAPER POINT
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “prolene”. A notice may cover another product or only some lots: read it to see what it covers.
- ETHIBOND EXCEL® , ETHIBOND®, PERMAHAND®, PROLENE® suturesJanuary 9, 2025 · General and plastic surgery · Sterility · Type II
- D-Special PROLENE Polypropylene Suture (2018-05-28)June 14, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.