IDENTITY,VERITY,INTEGRITY,VICTORY,ZEPHYR PACEMAKERS
FDA premarket approval P880086/S149 · decided 2007-10-29
Approval details
- PMA number
- P880086
- Supplement
- S149
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IDENTITY,VERITY,INTEGRITY,VICTORY,ZEPHYR PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-06-01
- Decision date
- 2007-10-29
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A MODIFICATION TO THE CLEANING PROCESS USED FOR THE HYBRIDS OF PACEMAKER DEVICES.
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