ENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE
FDA premarket approval P980035/S036 · decided 2004-03-31
Approval details
- PMA number
- P980035
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2004-03-02
- Decision date
- 2004-03-31
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADDITION OF THE ATRIAL CAPTURE MANAGEMENT (ACM) AND POST MODE SWITCH OVERDRIVE PACING (PMOP) FEATURES TO ENPULSE IMPLANTABLE PULSE GENERATOR MODELS E1DR01, E1DR03, E1DR06, AND E1DR21. IN ADDITION, YOU REQUESTED APPROVAL FOR MINOR UPDATES TO THE ASSOCIATED PROGRAMMER SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENPULSE IMPLANTABLE PULSE GENERATOR MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE.
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