ATTAIN OTW MODEL 4193
FDA premarket approval P010015/S003 · decided 2002-05-02
Approval details
- PMA number
- P010015
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Trade name
- ATTAIN OTW MODEL 4193
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2001-11-19
- Decision date
- 2002-05-02
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ATTAIN OTW 4193 LEFT VENTRICULAR PACING LEAD. THE MODEL 4193 IS INDICATED FOR USE AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.
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