INTERCEED ABSORBABLE ADHESION BARRIER
FDA premarket approval P880047/S003 · decided 1996-01-18
Approval details
- PMA number
- P880047
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTERCEED ABSORBABLE ADHESION BARRIER
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- ETHICON, Inc.
- Date received
- 1993-11-03
- Decision date
- 1996-01-18
- Days to decision
- 806 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- ALTERNATE STERILIZATION SITE, AS WELL AS A NEW MANUFACTURING SITE FOR BULK ROLL OF INTERCEED (TC7) ABSORBABLE ADHESION BARRIER
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