ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
FDA premarket approval P050011/S004 · decided 2013-07-02
Approval details
- PMA number
- P050011
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corp
- Date received
- 2013-06-06
- Decision date
- 2013-07-02
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Mcgaw Park, IL
- Statement
- REPLACE THE CURRENT PEPTIDOGLYCAN (PG) TEST METHOD WITH A HIGH SENSITIVITY PG (HS-PG) TEST METHOD.
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|---|---|---|
| PrisMax System Version 2 (K190910) | Baxter Healthcare Corp | 2019-07-25 |
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| LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO (K130245) | Baxter Healthcare Corp | 2013-03-01 |
| INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S (K123874) | Baxter Healthcare Corp | 2013-01-10 |
| INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET (K123868) | Baxter Healthcare Corp | 2013-01-08 |
| FLOWEASE [SUBCUTANEOUS] INFUSION SET (K121092) | Baxter Healthcare Corp | 2012-06-29 |