GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER
FDA premarket approval P880047/S021 · decided 2015-07-21
Approval details
- PMA number
- P880047
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- ETHICON, Inc.
- Date received
- 2015-06-19
- Decision date
- 2015-07-21
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- EXPAND THE EXISTING CLEAN MANUFACTURING ENVIRONMENT (CME) AREA IN YOUR SAN LORENZO MANUFACTURING FACILITY. IN ADDITION, THE 30-DAY NOTICE REQUESTED TO ADD A SECOND DEHUMIDIFICATION CHAMBER AS WELL AS ADD TWO ADDITIONAL FILLING BANKS (TO TOTAL FOUR FILLING STATIONS) INTO THIS NEW AREA.
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