FRONTIER II PACEMAKERS
FDA premarket approval P030035/S022 · decided 2006-10-13
Approval details
- PMA number
- P030035
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FRONTIER II PACEMAKERS
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-09-25
- Decision date
- 2006-10-13
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ALTERNATE ENCAPSULATION MATERIAL USED IN PACEMAKER HYBRID ASSEMBLIES.
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