INTERCEED TC7 ABSORBABLE ADHESION BARRIER
FDA premarket approval P880047/S005 · decided 1998-02-09
Approval details
- PMA number
- P880047
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERCEED TC7 ABSORBABLE ADHESION BARRIER
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- ETHICON, Inc.
- Date received
- 1997-12-03
- Decision date
- 1998-02-09
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for 1)the addition of an alternate 60 denier yarn constructed of 24 filaments instead of 18 filaments, and 2) the addition of the alternate final product release site of somerville, New Jersey. The device, as modified, will be marketed under the trade name INTERCEED*(TC7) and is indicated as an adhesion barrier to be used as an adjuvant to gynecologic pelvic surgery.
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