PASSIVE PLUS DX, MODELS 1336T, 1342T, 1343K, 1345K, 1346T
FDA premarket approval P960030/S009 · decided 2003-01-22
Approval details
- PMA number
- P960030
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PASSIVE PLUS DX, MODELS 1336T, 1342T, 1343K, 1345K, 1346T
- Generic name
- permanent pacemaker Electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 2002-12-04
- Decision date
- 2003-01-22
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING BRADYCARDIA LEADS.
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