TENDRIL/PASSIVE PLUS/AV PLUS DX
FDA premarket approval P960013/S006 · decided 1999-11-10
Approval details
- PMA number
- P960013
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TENDRIL/PASSIVE PLUS/AV PLUS DX
- Generic name
- permanent pacemaker Electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 1999-07-02
- Decision date
- 1999-11-10
- Days to decision
- 131 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the use of two alternate medical adhesives.
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510(k) clearances by this applicant
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|---|---|---|
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| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |