SURGICEL FAMILY OF ABSORBABLE HEMOSTATS
FDA premarket approval N12159/S035 · decided 2015-11-27
Approval details
- PMA number
- N12159
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL FAMILY OF ABSORBABLE HEMOSTATS
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2015-10-28
- Decision date
- 2015-11-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- IMPLEMENT A NEW CUSTOM DESIGNED PIECE OF AUTOMATED CUTTING EQUIPMENT TO CUT THE PRODUCT TO ITS FINAL FORM.
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