PDS Suture (Dyed)
by Ethicon Inc.
PMA N18331
Active
Valid until
No expiry
FDA recalls
None foundDocuments
PMA N18331
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberN18331 | Date14 Jul 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic name
- Suture, surgical, absorbable, polydioxanone
- FDA applicant
- ETHICON, Inc.
- PMA number
- FDA product code
- NEW
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4840
- Advisory committee
- General, Plastic Surgery
- FDA decision
- APPR Approved
- PMA supplement
- S006
Overview
AI-generated summary, 18 Sep 2026
The PDS Suture (Dyed) is an absorbable, surgical suture made from polydioxanone, a synthetic polymer designed for internal tissue approximation and wound closure. Its dyed formulation enhances visibility during surgical procedures, reducing the risk of needle loss or misplacement within tissue.
This suture is supplied in sterile, single-use packaging and is classified as a Class II medical device under FDA regulations. It is intended for use in general and plastic surgery settings, with various sizes available to accommodate different clinical applications. The product holds an FDA Premarket Approval (PMA) designation and is governed by regulation number 878.4840.
Other devices from Ethicon Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of surgical procedures is the PDS Suture (Dyed) primarily used for, and why is the dye important during surgery?
The PDS Suture (Dyed) is designed for internal tissue approximation and wound closure in general and plastic surgery settings. The dye enhances visibility during procedures, reducing the risk of needle loss or misplacement within tissue, which is particularly useful in delicate or deep surgical areas where visibility matters.
Is the PDS Suture (Dyed) meant for single-use only, and how should it be stored to maintain sterility?
Yes, the PDS Suture (Dyed) is supplied in sterile, single-use packaging, meaning it should only be used once and then discarded. To maintain sterility, it should be stored in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, until ready for use.
What sizes or models of the PDS Suture (Dyed) are available, and how do I determine the right size for a procedure?
The PDS Suture (Dyed) comes in multiple sizes, as indicated by the extensive list of FEI numbers in the specifications. While exact measurements aren’t provided here, these sizes are tailored for different clinical applications in general and plastic surgery. The appropriate size depends on the specific surgical needs, such as tissue thickness and the precision required for closure—consult the product packaging or manufacturer guidelines for matching the right size to your procedure.
How was the PDS Suture (Dyed) approved by the FDA, and what does this mean for its use in clinical settings?
The PDS Suture (Dyed) holds an FDA Premarket Approval (PMA) designation, meaning it underwent a rigorous review process to ensure safety and effectiveness for its intended use in internal tissue approximation and wound closure. This approval allows it to be legally marketed and used in clinical settings for general and plastic surgery procedures, adhering to FDA regulations under product code 878.4840.
Can the PDS Suture (Dyed) be reused, or is it designed for one-time use only?
The PDS Suture (Dyed) is explicitly supplied in sterile, single-use packaging, which means it is intended for one-time use only. Reusing it could compromise sterility and patient safety, so it should not be reused after a single surgical procedure.