PMA P840062S070
- Device
- CollaPlug Absorbable Collagen Wound Dressing For Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S070
- Product code
- LPG
- Decision date
- 2018-11-07
- Classification
- Material, Dressing, Surgical, Polylactic Acid
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Approval order statement
- Increasing the number of molds that may washed in the detergent wash and the number of times it may be reused (once) before draining and refilling.
Current openFDA PMA Record#
- Device
- CollaPlug Absorbable Collagen Wound Dressing For Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S070
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2018-11-07
- Decision code
- OK30
- Date received
- 2018-10-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increasing the number of molds that may washed in the detergent wash and the number of times it may be reused (once) before draining and refilling.