PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
FDA premarket approval N18331/S026 · decided 1995-09-07
Approval details
- PMA number
- N18331
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
- Generic name
- Suture, surgical, absorbable, polydioxanone
- Applicant
- ETHICON, Inc.
- Date received
- 1995-08-08
- Decision date
- 1995-09-07
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NEW
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
- 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
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