INTEGRA (ARTIFICIAL SKIN)
FDA premarket approval P900033/S002 · decided 1997-08-07
Approval details
- PMA number
- P900033
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTEGRA (ARTIFICIAL SKIN)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Integra Lifesciences Corp.
- Date received
- 1997-06-30
- Decision date
- 1997-08-07
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- APPROVAL FOR A 24 MONTH EXPIRATION DATE FOR INTEGRA ARTIFICIAL SKIN.
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510(k) clearances by this applicant
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|---|---|---|
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| CUSA Excel+ (K150682) | Integra Lifesciences Corp. | 2015-12-18 |
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| INTEGRA LICOX PTO2 MONITOR (K131184) | Integra Lifesciences Corp. | 2013-08-30 |
| JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS (K092227) | Integra Lifesciences Corp. | 2010-02-17 |