Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG
Medtronic, Inc. · Pulse generator, permanent, implantable · Cardiovascular
Open FDA's page for this record- PMA number
- P980035
- Supplement number
- S849
- Applicant
- Medtronic, Inc.
- Street 1
- 8200 Coral Sea St. N.E
- Street 2
- Ms Mvs11
- City
- Mounds View
- State
- MN
- Zip
- 55112
- Generic name
- Pulse generator, permanent, implantable
- Trade name
- Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG
- Product code
- NVZ
- 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
- 2026-10-15
- Decision date
- 2026-10-29
- Decision code
- OK30
- Ao statement
- a series of battery electrolyte fill manufacturing process updates at Medtronic Energy and Components Center
- Harmonized identifiers (openFDA)
- Device name
- Pulse Generator, Permanent, Implantable
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3008494315, 3008159616, 3009144177, 3013500228, 3005941719, 3018094310, 9614453, 3008973940, 3009380063, 3008483389, 9610139, 3002806603, 3003120897, 2135338, 3011120183, 3004593495, 3033257494, 1000165971, 3012552532, 3013596024, 3004209178, 1028232, 2017865, 3006705815, 2030624, 3015453963, 2024024, 2032521, 3005334138, 3013288201, 2649622, 2124215, 2133641, 2182208, 1220452
- FEI number
- 3008159616, 3009144177, 3000203466, 3013500228, 3018094310, 3008973940, 3002807576, 3009380063, 3000206435, 3008483389, 3002806603, 3003120897, 3002807111, 3011120183, 3004593495, 3004369318, 3033257494, 1000165971, 3005700659, 3012552532, 3013596024, 3003574398, 1028232, 3008377825, 2017865, 3006705815, 3015453963, 2024024, 3002806500, 3005334138, 3013288201, 2649622, 2124215, 2182208, 1220452