PMA P900033S018
- Device
- INTEGRA DERMAL REGENERATION TEMPLATE
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S018
- Product code
- MDD
- Decision date
- 2007-11-23
- Classification
- Device, Dermal Replacement
- Generic name
- Device, dermal replacement
- Approval order statement
- MODIFICATION AND RE-QUALIFICATION OF AN EXISTING CLEAN ROOM USED TO MANUFACTURE COLLAGEN HEMOSTATIC AGENTS.
Current openFDA PMA Record#
- Device
- INTEGRA DERMAL REGENERATION TEMPLATE
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S018
- Product code
- MDD
- Generic name
- Device, dermal replacement
- Decision date
- 2007-11-23
- Decision code
- OK30
- Date received
- 2007-10-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION AND RE-QUALIFICATION OF AN EXISTING CLEAN ROOM USED TO MANUFACTURE COLLAGEN HEMOSTATIC AGENTS.