ACTROS SLR PULSE GENERATOR
FDA premarket approval P950037/S013 · decided 2000-10-13
Approval details
- PMA number
- P950037
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACTROS SLR PULSE GENERATOR
- Generic name
- permanent pacemaker Electrode
- Applicant
- Biotronik, Inc.
- Date received
- 2000-05-08
- Decision date
- 2000-10-13
- Days to decision
- 158 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR REMOVAL OF THE WARNING LABEL WHICH RECOMMENDED PROGRAMMING DYNAMIC HYSTERESIS ON WHEN THE DEVICE IS PROGRAMMED TO THE VDDR MODE.
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510(k) clearances by this applicant
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