COLLACOTE(TM)
FDA premarket approval P840062/S055 · decided 2016-03-17
Approval details
- PMA number
- P840062
- Supplement
- S055
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLACOTE(TM)
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2016-02-19
- Decision date
- 2016-03-17
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Replacement of the current Wet Processing Dispersion Tanks #3 and #4, located in the 105 Morgan Lane Medical Manufacturing Suite Room 407, used to produce collagen dispersions for medical devices. Both of these tanks will be replaced by Wet Processing Dispersion Tanks #6 and #5, respectively. Both tanks are fabricated by the same vendor and according to the same specifications and drawings as the existing tank.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Codman Disposable Perforators (K183581) | Integra Lifesciences Corp. | 2019-01-20 |
| CereLink ICP Monitor, CereLink ICP Extension Cable (K183406) | Integra Lifesciences Corp. | 2019-01-11 |
| CodMan Certas Plus Programmable Valve (K182265) | Integra Lifesciences Corp. | 2018-11-20 |
| Codman Certas Plus Electronic Tool Kit (K181902) | Integra Lifesciences Corp. | 2018-10-25 |
| CUSA Excel+ (K150682) | Integra Lifesciences Corp. | 2015-12-18 |
| Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs (K150428) | Integra Lifesciences Corp. | 2015-04-16 |
| 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 |