COLLACOTE, COLLATAPE, COLLAPLUG, ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
FDA premarket approval P840062/S047 · decided 2015-04-16
Approval details
- PMA number
- P840062
- Supplement
- S047
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLACOTE, COLLATAPE, COLLAPLUG, ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2015-03-20
- Decision date
- 2015-04-16
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- MATERIAL CHANGE FOR THE PIPE THAT LEADS TO CROSSLINKING CHAMBER 2, AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.
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