Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8
Biotronik, Inc. · implantable pacemaker Pulse-generator · Cardiovascular
Open FDA's page for this record- PMA number
- P950037
- Supplement number
- S299
- Applicant
- Biotronik, Inc.
- Street 1
- 6024 Jean Rd.
- City
- Lake Oswego
- State
- OR
- Zip
- 97035
- Generic name
- implantable pacemaker Pulse-generator
- Trade name
- Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8
- Product code
- DXY
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-09-22
- Decision date
- 2026-10-22
- Decision code
- OK30
- Ao statement
- updating visual and dimensional incoming inspection testing for certain components and raw materials used in IPG, ICD, and lead manufacturing
- Harmonized identifiers (openFDA)
- Device name
- Implantable Pacemaker Pulse-Generator
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.3610
- Device class
- 3
- Registration number
- 3018094310, 2649622, 3008159616, 2124215, 3008483389, 3033257494, 9614453, 3003120897, 3002806603, 2024024, 2133641, 1028232, 2017865, 3005334138, 3012552532, 3008494315, 2182208, 3013288201, 2032521, 1000165971, 2648729, 3004593495, 3004209178, 3006705815, 2135338, 9610139, 3008973940, 3009380063
- FEI number
- 3000203466, 3002807576, 3018094310, 2649622, 3008159616, 2124215, 3008483389, 3033257494, 3003120897, 3002806603, 2024024, 3003574398, 1028232, 2017865, 3005334138, 3012552532, 3002806500, 3005700659, 2182208, 3013288201, 3004369318, 1000165971, 2648729, 3008377825, 3004593495, 3006705815, 3008973940, 3009380063