VITAGEL SURGICAL HEMOSTAT
FDA premarket approval P990030/S005 · decided 2004-09-13
Approval details
- PMA number
- P990030
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITAGEL SURGICAL HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Angiotech Medical Device Technologies
- Date received
- 2004-08-23
- Decision date
- 2004-09-13
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- APPROVAL FOR A NEW TRADE NAME FOR THE DEVICE PREVIOUSLY KNOWN AS THE COSTASIS/DYNASTAT SURGICAL HEMOSTAT: THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL SURGICAL HEMOSTAT AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
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