PMA N18331S026

Device: PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
Applicant: ETHICON, Inc.
PMA number: N18331
Supplement: S026
Product code: NEW
Decision date: 1995-09-07
Generic name: Suture, surgical, absorbable, polydioxanone
Approval order statement: APPROVAL FOR A CHANGE IN THE STERILIZATION PROCESS FROM USE OF ETHYLENE OXIDE/FREON GAS MIXTURE OR ETHYLENE OXIDE/NITROGEN MIXTURE TO ETHYLENE OXIDE/OXYFUME GAS MIXTURE

Current openFDA PMA Record#

Device: PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
Applicant: ETHICON, Inc.
PMA number: N18331
Supplement: S026
Product code: NEW
Generic name: Suture, surgical, absorbable, polydioxanone
Decision date: 1995-09-07
Decision code: APPR
Date received: 1995-08-08
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE STERILIZATION PROCESS FROM USE OF ETHYLENE OXIDE/FREON GAS MIXTURE OR ETHYLENE OXIDE/NITROGEN MIXTURE TO ETHYLENE OXIDE/OXYFUME GAS MIXTURE