PMA P870078S037
- Device
- Hancock Valved Conduiis
- Applicant
- Medtronic, Inc.
- PMA number
- P870078
- Supplement
- S037
- Product code
- DYE
- Decision date
- 2017-12-13
- Classification
- Replacement Heart-valve
- Generic name
- replacement Heart-valve
- Approval order statement
- Approval for a transfer of manufacturing operations to a new controlled environment area within the same manufacturing site.
Current openFDA PMA Record#
- Device
- Hancock Valved Conduiis
- Applicant
- Medtronic, Inc.
- PMA number
- P870078
- Supplement
- S037
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2017-12-13
- Decision code
- APPR
- Date received
- 2017-08-14
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a transfer of manufacturing operations to a new controlled environment area within the same manufacturing site.