LOCATOR STEERABLE STYLET
FDA premarket approval P960013/S005 · decided 1999-04-09
Approval details
- PMA number
- P960013
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LOCATOR STEERABLE STYLET
- Generic name
- permanent pacemaker Electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 1999-03-04
- Decision date
- 1999-04-09
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for changes to the User's Manual and package label for the Locator(TM) Steerable Stylet Model 4036.
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