LEAD FIXATION SLEEVE
FDA premarket approval P070008/S013 · decided 2009-10-28
Approval details
- PMA number
- P070008
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LEAD FIXATION SLEEVE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Biotronik, Inc.
- Date received
- 2009-09-30
- Decision date
- 2009-10-28
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR COROX OTW LEAD FIXATION SLEEVE (EFH) MODIFICATIONS. THE DEVICE IS INDICATED FOR USE ON COROX OTW BP LEADS TO PROVIDE PACING AND/OR SENSING.
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510(k) clearances by this applicant
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