ADEPT ADHESION REDUCTION SOLUTION
FDA premarket approval P050011/S001 · decided 2008-02-07
Approval details
- PMA number
- P050011
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADEPT ADHESION REDUCTION SOLUTION
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corp
- Date received
- 2008-01-09
- Decision date
- 2008-02-07
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Mcgaw Park, IL
- Statement
- RELOCATION OF THE QUALITY SYSTEM TO BAXTER AG, VIENNA, AUSTRIA AND CHANGING THE CONTRACT TEST LABORATORY TO THE MATERIAL MANUFACTURER CARGILL?S TESTING LABORATORY.
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