INSTAT COLLAGEN HEMOSTAT
FDA premarket approval P830079/S015 · decided 2004-06-22
Approval details
- PMA number
- P830079
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSTAT COLLAGEN HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2004-04-28
- Decision date
- 2004-06-22
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO; AND A LOWERED MINIMUM RADIATION STERILIZATION DOSE.
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