PMA N18331S025
- Device
- PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
- Applicant
- ETHICON, Inc.
- PMA number
- N18331
- Supplement
- S025
- Product code
- NEW
- Decision date
- 1995-11-02
- Generic name
- Suture, surgical, absorbable, polydioxanone
- Approval order statement
- APPROVAL FOR USE OF THE PDS II SUTURE IN HTE PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM
Current openFDA PMA Record#
- Device
- PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
- Applicant
- ETHICON, Inc.
- PMA number
- N18331
- Supplement
- S025
- Product code
- NEW
- Generic name
- Suture, surgical, absorbable, polydioxanone
- Decision date
- 1995-11-02
- Decision code
- APPR
- Date received
- 1995-05-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR USE OF THE PDS II SUTURE IN HTE PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM