ATTAIN OTW 4193 LEFT VENTRICULAR PACING LEAD
FDA premarket approval P010015/S007 · decided 2002-12-23
Approval details
- PMA number
- P010015
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ATTAIN OTW 4193 LEFT VENTRICULAR PACING LEAD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2002-06-28
- Decision date
- 2002-12-23
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
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