Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar
Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT) · Cardiovascular
Open FDA's page for this record- PMA number
- P010015
- Supplement number
- S591
- Applicant
- Medtronic, Inc.
- Street 1
- 8200 Coral Sea St. N.E
- Street 2
- Ms Mvs11
- City
- Mounds View
- State
- MN
- Zip
- 55112
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Trade name
- Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar
- Product code
- LWP
- 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
- 2026-09-24
- Decision date
- 2026-10-23
- Decision code
- OK30
- Ao statement
- the introduction of a second Medium Rate (MR) Headers manufacturing line and to make inspection updates to the MR Headers Line that is currently in production
- Harmonized identifiers (openFDA)
- Device name
- Implantable Pulse Generator, Pacemaker (Non-Crt)
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3018094310, 2649622, 3008159616, 2124215, 3008483389, 3033257494, 9614453, 3003120897, 3002806603, 2024024, 2133641, 9616693, 1028232, 2017865, 3005334138, 3012552532, 3013596024, 3013500228, 3008494315, 1220452, 3003932293, 3004105270, 2182208, 3013288201, 2032521, 1000165971, 2648729, 3004209178, 3006705815, 1450662, 1721676, 2135338, 9610139, 3008973940, 3009380063
- FEI number
- 3000203466, 3002807576, 3018094310, 2649622, 3008159616, 2124215, 3008483389, 3033257494, 3003120897, 3002806603, 2024024, 3003574398, 1028232, 2017865, 3005334138, 3012552532, 3002806500, 3005700659, 3013596024, 3013500228, 1220452, 3003932293, 3002618605, 3004105270, 2182208, 3013288201, 3004369318, 1000165971, 2648729, 3008377825, 3006705815, 1450662, 1721676, 3008973940, 3009380063