INTERCEED (TC7) ABSORBABLE ADHESION BARRIER
FDA premarket approval P880047/S008 · decided 2003-10-21
Approval details
- PMA number
- P880047
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- INTERCEED (TC7) ABSORBABLE ADHESION BARRIER
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- ETHICON, Inc.
- Date received
- 2003-09-04
- Decision date
- 2003-10-21
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS-ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO.
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