PMA P900033S021
- Device
- INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (IDRT-TS)
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S021
- Product code
- MDD
- Decision date
- 2012-05-24
- Classification
- Device, Dermal Replacement
- Generic name
- Device, dermal replacement
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH AST, LLC IN DENVER, COLORADO.
Current openFDA PMA Record#
- Device
- INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (IDRT-TS)
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S021
- Product code
- MDD
- Generic name
- Device, dermal replacement
- Decision date
- 2012-05-24
- Decision code
- APPR
- Date received
- 2011-10-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH AST, LLC IN DENVER, COLORADO.