Absorbable Collagen Plug for Dental Surgery, Absorbable Collagen Tape for Dental Surgery
FDA premarket approval P840062/S068 · decided 2019-02-22
Approval details
- PMA number
- P840062
- Supplement
- S068
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Absorbable Collagen Plug for Dental Surgery, Absorbable Collagen Tape for Dental Surgery
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2018-08-27
- Decision date
- 2019-02-22
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Approval for additional trade names: Absorbable Collagen Tape for Dental Surgery and Absorbable Collagen Plug for Dental Surgery.
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510(k) clearances by this applicant
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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 |